Husholdningernes luftforurening og sundhed: Et LPG-interventionsforsøg i flere lande (HAPIN)
7. maj 2026 opdateret af: Thomas Clasen, Emory University
Denne undersøgelse er et randomiseret kontrolleret forsøg med gas- og brændstofdistribution i 3.200 husstande i fire lande (Indien, Guatemala, Peru og Rwanda).
Efter en fælles protokol vil hvert interventionssted rekruttere 800 gravide kvinder (i alderen 18-34 år, 9 - <20 ugers svangerskab) og vil tilfældigt tildele halvdelen af deres husstande til at modtage LPG-ovne og en 18-måneders forsyning af LPG.
Kontrolhusholdninger forventes at fortsætte med at lave mad primært med fast biomassebrændsel og vil modtage kompensation baseret på et ensartet sæt af forsøgsdækkende principper, tilpasset hvert sted baseret på formativ forskning.
Moderen vil blive fulgt sammen med sit barn, indtil barnet er 1 år.
Forskerne anslår, at 15 % af husstandene vil have en anden, ikke-gravid ældre voksen kvinde (i alderen 40 til <80 år), som også vil blive tilmeldt ved baseline og fulgt i løbet af den 18-måneders opfølgningsperiode.
For at optimere brugen af interventioner vil forskerne implementere adfærdsændringsstrategier baseret på tidligere erfaringer og formativ forskning i år 1.
Denne undersøgelse vil vurdere brugen af komfurer, udføre gentagne personlige eksponeringsvurderinger af husholdningernes luftforurening og indsamle tørrede blodpletter og urinprøver til biomarkøranalyse og opbevaring af bioprøver.
De primære resultater er lav fødselsvægt, forekomst af alvorlig lungebetændelse og svækkelse af barnet og blodtryk hos den ældre voksne kvinde.
Sekundære resultater omfatter for tidlig fødsel og udvikling hos barnet, moderens blodtryk under graviditeten og endotelfunktion, åndedrætsnedsættelse, åreforkalkning, kræftfremkaldende metabolitter og livskvalitet hos den ældre voksne kvinde.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
På verdensplan er næsten 3 milliarder mennesker afhængige af fast brændsel til madlavning og opvarmning, langt de fleste i lav- og mellemindkomstlande (LMIC'er). Den resulterende husholdningsluftforurening (HAP) er den tredje førende risikofaktor i den globale sygdomsbyrde i 2010 og tegner sig for anslået 4,3 millioner dødsfald årligt, hovedsageligt blandt kvinder og små børn. Tidligere interventioner har givet renere biomassebaserede kogeovne, men har ikke formået at reducere eksponeringen til niveauer, der giver meningsfulde sundhedsforbedringer. Der har ikke været nogen storstilet feltforsøg med kogeovne til flydende petroleumsgas (LPG), sandsynligvis den reneste skalerbare intervention.
Formålet med denne undersøgelse er at udføre et randomiseret kontrolleret forsøg med distribution af LPG-ovne og brændstof i 3.200 husstande i fire LMIC'er (Indien, Guatemala, Peru og Rwanda) for at levere strenge beviser vedrørende potentielle sundhedsmæssige fordele gennem hele levetiden. Hvert interventionssted vil rekruttere 800 gravide kvinder (i alderen 18-34 år, 9 - <20 ugers svangerskab) og vil tilfældigt tildele halvdelen af deres husstande til at modtage LPG-ovne og en 18-måneders forsyning af LPG. Kontrolhusholdninger forventes at fortsætte med at lave mad primært med fast biomassebrændsel og vil modtage kompensation baseret på et ensartet sæt af forsøgsdækkende principper, tilpasset hvert sted baseret på formativ forskning. Moderen vil blive fulgt sammen med sit barn, indtil barnet er 1 år. I husstande med en anden, ikke-gravid ældre voksen kvinde (i alderen 40 til <80 år) vil forskerne også tilmelde sig og følge hende i den 18-måneders opfølgningsperiode for at vurdere hjerte-lunge-, stofskifte- og kræftudfald. For at optimere brugen af interventioner vil forskerne implementere adfærdsændringsstrategier. Denne undersøgelse vil vurdere brugen af komfurer, udføre gentagne personlige eksponeringsvurderinger for HAP (PM2.5, sort kulstof, kulilte) og indsamle tørrede blodpletter og urinprøver til biomarkøranalyse og opbevaring af bioprøver på alle deltagere på flere tidspunkter. De primære resultater er lav fødselsvægt, forekomst af alvorlig lungebetændelse og svækkelse af barnet og blodtryk hos den ældre voksne kvinde. Sekundære resultater omfatter for tidlig fødsel og udvikling hos barnet, moderens blodtryk under graviditeten og endotelfunktion, åndedrætsnedsættelse, åreforkalkning, kræftfremkaldende metabolitter og livskvalitet hos den ældre voksne kvinde.
Denne undersøgelse vil adressere følgende specifikke mål: (1) ved hjælp af en intention-to-treat-analyse, bestemme effekten af en randomiseret LPG-ovn og brændstofintervention på sundheden i fire forskellige LMIC-populationer ved hjælp af en fælles protokol; (2) bestemme eksponering-respons-relationerne for HAP og sundhedsresultater; og (3) bestemme forholdet mellem LPG-intervention og både målrettede og udforskende biomarkører for eksponering/sundhedseffekter.
Denne undersøgelse vil give beviser, herunder omkostninger og implementeringsstrategier, for at informere nationale og globale politikker om opskalering af LPG-ovne blandt sårbare befolkningsgrupper. I sidste ende vil dette lette dybere diskussioner på politikniveau samt identificere krav til at igangsætte og opretholde HAP-interventioner globalt.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3640
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Departamento de Guatemala
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Guatemala City, Departamento de Guatemala, Guatemala, 01015
- Universidad del Valle de Guatemala
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Tamil Nadu
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Chennai, Tamil Nadu, Indien, 600116
- Sri Ramachandra Institute of Higher Education and Research
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Puno, Peru
- Puno Global Non-Communicable Disease Research Site, School of Medicine, Johns Hopkins University
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Kigali, Rwanda
- Rwanda Research Site, London School of Hygiene and Tropical Medicine, University of Liverpool
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 79 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier for gravide:
- Bekræftet graviditet (hCG positiv blod- eller urinprøve)
- I alderen 18 til <35 år (via selvrapportering)
- Bruger overvejende biomasseovn
- Bor i studieområdet
- 9 - <20 ugers graviditet bekræftet ved ultralyd
- Singleton graviditet (et foster)
- Levedygtigt foster med normal føtal hjertefrekvens (120-180 slag i minuttet) på tidspunktet for ultralyd
- Fortsat graviditet på tidspunktet for randomisering bekræftet ved selvrapportering
- Indvilliger i at deltage med informeret samtykke
Eksklusionskriterier for gravide kvinder:
- Ryger i øjeblikket cigaretter eller andre tobaksvarer
- Planlægger at flytte permanent uden for studieområdet inden for de næste 12 måneder
- Bruger overvejende LPG-ovn, eller vil sandsynligvis overvejende bruge LPG i den nærmeste fremtid
Inklusionskriterier for ældre voksen kvinde i samme husstand:
- I alderen 40 til <80 år (via selvrapportering)
Eksklusionskriterier for ældre voksen kvinde i samme husstand:
- Ryger i øjeblikket cigaretter eller andre tobaksvarer
- Gravid (ved selvrapportering)
- Planlægger at flytte ud af sin nuværende husstand inden for de næste 12 måneder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Kogeovn til flydende gas
Deltagere, der er randomiseret til den eksperimentelle arm, vil modtage en kogeovn til flydende petroleumsgas (LPG) og 18-måneders forsyning af LPG.
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The intervention consists of a high-quality locally available liquefied petroleum gas (LPG) stove having at least two burners, a continuous supply of LPG fuel for 18 months, and the promotion of stove use on an exclusive basis for cooking.
The intervention will be provided free of charge to all intervention households upon enrollment.
On a weekly basis, study staff will examine stove condition, perform any necessary repairs, and measure and record weight of LPG tanks in order to anticipate need for refills.
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Ingen indgriben: Styring
Deltagerne i kontrolgruppen modtager ikke et komfur til flydende petroleumsgas (LPG) og vil fortsætte med at bruge traditionelle tilberedningsmetoder (åben ild eller traditionelle komfurer) eller tilberedningsmetoden efter eget valg.
Kontrolhusstande vil modtage kompensation baseret på et ensartet sæt af forsøgsdækkende principper, tilpasset hvert sted baseret på formativ forskning.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Birth weight
Tidsramme: Within 24 hours of birth (up to 5 months post-randomization of mother)
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Birth weight is assessed by a trained nurse or health worker within 24 hours of birth.
Infants are weighed naked or in a pre-weighed blanket.
Weight is measured to the nearest 10 g using a digital electronic scale, if performed by the study field staff; otherwise, hospital medical records are used.
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Within 24 hours of birth (up to 5 months post-randomization of mother)
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Incidence of HAPIN Defined Severe Pneumonia
Tidsramme: Up to 12 months after birth
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The number of times a child has severe pneumonia over their period of follow-up during the first year of life is assessed.
For this study pneumonia criteria are adapted from the WHO classification of childhood pneumonia (2014) and there are 3 algorithms for case criteria: 1) the presence of cough and/or difficult breathing and at least 1 general danger sign plus evidence of pneumonia on lung imaging (i.e., lung ultrasound or chest x-ray), or 2) the presence of cough and/or difficult breathing and hypoxemia (measured either via pulse oximetry (SpO2), or observing a child requiring advanced respiratory support (i.e., intubation and mechanical ventilation, non-invasive ventilation with continuous or bi-level positive airway pressure support, or high-flow nasal cannula oxygen), or 3) children who die prior to evaluation but their death is attributed to pneumonia by verbal autopsy.
Cases of pneumonia are recorded children present to HAPIN health facilities with respiratory symptoms.
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Up to 12 months after birth
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Length-for-age z-score 2 standard deviations below the standard
Tidsramme: 12 months after birth
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The primary outcome measured is stunting at one year of age, defined as a length-for-age z-score (LAZ) that is 2 standard deviations below the median of the growth standard.
Infant length is assessed at birth and quarterly thereafter, until the child is 12 months old.
Z-scores are calculated using the 2006 World Health Organization (WHO) Multi-Growth Reference Standard (MGRS).
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12 months after birth
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Systolic Blood Pressure Among Older Adult Women
Tidsramme: Baseline, 3, 6, 9, 12, and 18 months post-randomization
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Systolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline, 3, 6, 9, 12, and 18 months post-randomization
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Child Linear Growth During Extended Follow-up
Tidsramme: 24, 36, 48 and 60 months of age
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Linear growth of children is assessed in centimeters of height.
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24, 36, 48 and 60 months of age
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Caregiver Reported Early Childhood Development Instrument (CREDI) Score During Extended Follow-up
Tidsramme: 24 months of age
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Child development is assessed with the Caregiver Reported Early Childhood Development Instrument (CREDI).
The CREDI is a population-level measure of early childhood development (ECD) for children from 0-3 years of age.
The CREDI assesses 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) social-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence).
The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child.
Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded.
Both domain-specific and overall z-scores are calculated.
Total raw scores increase by age (with developmental progression), and higher scores indicate increased development.
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24 months of age
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Malawi Developmental Assessment Tool (MDAT) Score
Tidsramme: 36, 48 and 60 months of age
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The MDAT measures gross motor (39 items), fine motor (42 items), language/cognition (40 items) and social skills (36 items).
Originally developed and validated in rural Malawi, it has now been used in over 25 countries with more than 8,000 children as both a clinical and research tool.
The MDAT is a continuous test with start and stop rules.
Most items are administered directly to the child and items that are not easily observed (e.g., child speaks in full sentences; child understands sharing with others; child can dress self) are administered by parent report.
Children receive either a pass or fail for each item, and summed pass scores can produce a composite score as well as domain-specific scores.
Total scores range from 0 to 157 where higher scores indicate greater neurodevelopment.
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36, 48 and 60 months of age
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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For tidlig fødsel
Tidsramme: Op til 5 måneder (inden for 24 timer efter fødslen, 3-5 måneder efter randomisering)
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For tidlig fødsel er defineret som levering af et levende spædbarn før 37 afsluttede svangerskabsuger.
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Op til 5 måneder (inden for 24 timer efter fødslen, 3-5 måneder efter randomisering)
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Hospitalsindlæggelse for luftvejssygdom
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af hospitalsindlæggelser for en luftvejssygdom i løbet af det første leveår.
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Op til 12 måneder efter fødslen
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WHO ikke-svær lungebetændelse
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af ikke-svær lungebetændelse fra WHO (definition 2014 og 2013 definition) i løbet af det første leveår.
Tilfælde af lungebetændelse registreres, når børn møder op på HAPIN sundhedsfaciliteter med luftvejssymptomer.
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Op til 12 måneder efter fødslen
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WHO alvorlig lungebetændelse
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af ikke-svær lungebetændelse fra WHO (definition 2014 og 2013 definition) i løbet af det første leveår.
Tilfælde af lungebetændelse registreres, når børn møder op på HAPIN sundhedsfaciliteter med luftvejssymptomer.
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Op til 12 måneder efter fødslen
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WHO Pocket Book Ikke-alvorlig lungebetændelse
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af ikke-svær lungebetændelse fra WHO i løbet af det første leveår, som defineret i anden udgave af "Pocket book of hospital care for children" (2013).
Tilfælde af lungebetændelse registreres, når børn møder op på HAPIN sundhedsfaciliteter med luftvejssymptomer.
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Op til 12 måneder efter fødslen
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WHO Pocket Book Alvorlig lungebetændelse
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af WHOs alvorlige lungebetændelse i løbet af det første leveår, som defineret i anden udgave af "Pocket book of hospital care for children" (2013).
Tilfælde af lungebetændelse registreres, når børn møder op på HAPIN sundhedsfaciliteter med luftvejssymptomer.
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Op til 12 måneder efter fødslen
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Hypoxæmisk lungebetændelse
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af hypoxæmisk lungebetændelse i løbet af det første leveår.
Tilfælde af lungebetændelse registreres, når børn møder op på HAPIN sundhedsfaciliteter med luftvejssymptomer.
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Op til 12 måneder efter fødslen
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Ultralyd eller røntgen lungebetændelse
Tidsramme: Op til 12 måneder efter fødslen
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Kumulativ forekomst af lunge-ultralyd eller lungebetændelse med røntgen af thorax i løbet af det første leveår.
Tilfælde af lungebetændelse registreres, når børn møder op på HAPIN sundhedsfaciliteter med luftvejssymptomer.
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Op til 12 måneder efter fødslen
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Gestational Systolic Blood Pressure
Tidsramme: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Gestational Diastolic Blood Pressure
Tidsramme: Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Blood pressure is assessed in the pregnant women in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline (9-20 weeks gestation), 24-28 and 32-36 weeks gestation
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Systolic Blood Pressure in New Mothers
Tidsramme: 9, 12, and 18 months post-randomization
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Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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9, 12, and 18 months post-randomization
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Diastolic Blood Pressure in New Mothers
Tidsramme: 9, 12, and 18 months post-randomization
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Blood pressure is assessed in the new mothers in the intervention and control arms using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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9, 12, and 18 months post-randomization
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Diastolic Blood Pressure Among Older Adult Women
Tidsramme: Baseline, 3, 6, 12 and 18 months post-randomization
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Diastolic blood pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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Baseline, 3, 6, 12 and 18 months post-randomization
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Mean arterial pressure
Tidsramme: Baseline, 3, 6, 12 and 18 months post-randomization
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Mean arterial pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
Mean arterial pressure is calculated as DBP+(SBP-DBP)/3, where SBP=systolic blood pressure and DBP=diastolic blood pressure.
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Baseline, 3, 6, 12 and 18 months post-randomization
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Pulse pressure
Tidsramme: Baseline, 3, 6, 12 and 18 months post-randomization
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Pulse pressure is assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan).
pressure.
Pulse pressure is the difference between systolic blood pressure and diastolic blood pressure.
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Baseline, 3, 6, 12 and 18 months post-randomization
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Fetal Growth
Tidsramme: Baseline, Gestation Week 24-28 and Gestation Week 32-36
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Pregnant women have ultrasounds at Baseline and during gestation weeks 24-28 and gestation weeks 32-36 to measure fetal growth outcomes.
Specifically, the researchers evaluate head circumference (HC), abdominal circumference (AC), femur length (FL) and estimated fetal weight (EFW) during gestation.
The researchers are comparing (i) z-scores of individual fetal growth measurements (HC, AC, FL, EFW) at the 2 growth ultrasound visits between intervention and control participants (separately at 24-28 weeks gestation and 32-36 weeks gestation); (ii) differences in proportions of the 2.5th percentiles of each of these measurements evaluated separately at 24-28 and 32-36 weeks gestation; (iii) Z-score trajectories of HC, AC, FL and EFW as a function of gestational age and intervention; and (iv) prevalence of small for gestational age (SGA) during the fetal period through birth as measured by WHO INTERGROWTH 21st standards.
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Baseline, Gestation Week 24-28 and Gestation Week 32-36
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Gestational age at birth
Tidsramme: Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
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Gestational age at birth is measured in weeks, as continuous outcome, among all live births.
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Up to 5 months (within 24 hours of birth, 3-5 months post randomization)
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Brachial artery reactivity testing (BART)
Tidsramme: Baseline, 18 months post-randomization
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Brachial artery reactivity testing (BART) measures endothelial function via flow-mediated dilatation to reactive hyperemia following the release of arm blood-flow occlusion.
In this test, baseline artery diameter is measured, then a blood pressure cuff is inflated to induce distal arm ischemia for 5 minutes and after releasing the pressure, the post-occlusion brachial artery diameter is measured.
The ratio of post- to pre-occlusion artery diameter represents endothelial function where lower values indicate worse endothelial function.
(Peru only)
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Baseline, 18 months post-randomization
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Carotid intima-media thickness (CIMT) Among Older Adult Women
Tidsramme: Baseline, 18 months post-randomization
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The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease.
The test measures the thickness of the inner two layers of the carotid artery and can detect plaque build up prior to physical symptoms being experienced.
The carotid ultrasound will be performed with a portable ultrasound by trained sonographers.
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Baseline, 18 months post-randomization
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St. George Respiratory Questionnaire (SGRQ) Score
Tidsramme: Baseline, 18 months post-randomization
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Adult respiratory health and well-being is assessed with the St. George Respiratory Questionnaire (SGRQ).
The SGRQ measures impaired health and perceived well-being among individuals with chronic airway disease.
The SGRQ has sections assessing symptoms, activities that cause breathlessness or are limited because of breathlessness, and the impacts of respiratory problems on employment, sense of control of health, panic, stigmatization, medication use, side effects of therapies, expectations for health and disturbances of daily life.
The questionnaire includes multiple choice, true/false and open-ended questions.
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Baseline, 18 months post-randomization
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Short Form 36 Survey (SF-36) Score Among Older Adult Women
Tidsramme: Baseline, 18 months post-randomization
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The Short Form 36 survey (SF-36) is a standardized, preference-based 36 item questionnaire evaluating quality of life.
The survey has 8 sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health).
Possible scores range from 0 (lowest quality of life) to 100 (highest quality of life).
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Baseline, 18 months post-randomization
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Weight
Tidsramme: 24, 36, 48 and 60 months of age of the child
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Weight is measured in kilograms (kg).
Weight in new mothers in Rwanda is measured when the child is 24 months old.
For new mothers in Guatemala weight is measured when the child is 24 and 36 months old.
In older adult women, weight is measured when the child is 24 months old.
Weight is measured in children at 24, 36, 48 and 60 months of age.
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24, 36, 48 and 60 months of age of the child
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Body Mass Index (BMI)
Tidsramme: 24, 36, 48 and 60 months of age of the child
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BMI is calculated as weight in kilograms divided by height in meters (m) squared (kg/m^2).
BMI in new mothers in Rwanda is calculated from height and weight measurements obtained when the child is 24 months old.
For new mothers in Guatemala BMI is calculated from height and weight measurements obtained when the child is 24 and 36 months old.
In older adult women, BMI is calculated from height and weight measurements obtained when the child is 24 months old.
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24, 36, 48 and 60 months of age of the child
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Height
Tidsramme: 24 and 36 months of age of the child
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Height is measured in meters.
Height in new mothers in Rwanda is measured when the child is 24 months old.
For new mothers in Guatemala height is measured when the child is 24 and 36 months old.
In older adult women, height is measured when the child is 24-months old.
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24 and 36 months of age of the child
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Child Blood Pressure
Tidsramme: 24 (Rwanda only) and 60 months of age
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Blood pressure is assessed in the children using automatic sphygmomanometers (OMRON HEM-907XL; Osaka, Japan).
The study team uses the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.
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24 (Rwanda only) and 60 months of age
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Child Linear Growth
Tidsramme: Birth (3-5 months post-randomization), and 3, 6, 9, and 12 months of age
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Linear growth of children is assessed in centimeters at birth and quarterly thereafter, until the child is 12 months old.
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Birth (3-5 months post-randomization), and 3, 6, 9, and 12 months of age
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Caregiver Reported Early Childhood Development Instrument (CREDI) Score
Tidsramme: 3 and 12 months of age
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Child development is assessed with the Caregiver Reported Early Childhood Development Instrument (CREDI).
The CREDI is a population-level measure of early childhood development (ECD) for children from 0-3 years of age.
The CREDI assesses 4 domains of child development: 1) motor (fine and gross motor), 2) language (expressive and receptive language), 3) cognitive (executive function, problem solving and reasoning, and pre-academic knowledge), and 4) social-emotional (emotional and behavioral self-regulation, emotional knowledge, and social competence).
The CREDI long form consists of up to 108 items and the number of questions answered depends on the age of the child.
Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded.
Both domain-specific and overall z-scores are calculated.
Total raw scores increase by age (with developmental progression), and higher scores indicate increased development.
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3 and 12 months of age
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Spontan abort
Tidsramme: Baseline gennem 20 ugers graviditet
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Fosterdød inden 19 uger 6 dage.
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Baseline gennem 20 ugers graviditet
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Tidlig for tidlig fødsel
Tidsramme: Fødsel
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Fødsler under 34 uger afsluttet svangerskab blandt alle levende fødte.
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Fødsel
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Dødfødsel
Tidsramme: Op til fødslen
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Eventuelle føtale dødsfald, der forekommer ved eller efter 20 ugers svangerskab, ELLER angivet på skemaet Alvorlige bivirkninger ELLER på skemaet til gravid kvindes sygehistorie ELLER på det verbale obduktionsskema.
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Op til fødslen
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Neonatal død
Tidsramme: Fødsel gennem 28 dage
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Død mellem fødslen og 28 dage.
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Fødsel gennem 28 dage
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Barnets lungefunktion
Tidsramme: 36, 48 og 60 måneder
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Lungefunktionsmålinger vil blive foretaget ved hjælp af forceret oscillationsteknikken (FOT) med Tremoflo C-100 enheden med engangsmundstykker.
FOT er en teknik, der kan identificere tidlige ændringer i luftvejene.
FOT-enheden måler forholdet mellem eksternt påførte trykbølger og den resulterende luftstrøm for at måle respirationsimpedansen.
Værdier produceret ved høje frekvenser svarer til de proksimale og store luftveje, og værdier produceret ved lave frekvenser svarer til distale og små luftveje.
Denne måling vil blive udført på børn i Guatemala.
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36, 48 og 60 måneder
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Ændring i urinbiomarkører
Tidsramme: Baseline, 3, 6, 9, 12 og 18 måneder efter randomisering og barnets 24 måneders alder
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Biomarkører for flere eksponeringer vil blive målt: 3-OH Cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), levoglucosan, 8OH-deoxyguanosin (8OHdG) og flygtige organiske kemikalier (VOC) metabolitter .
Eksponeringsbiomarkører (især for børn, hvis urin kan være begrænset) vil blive prioriteret som følger: polycykliske aromatiske kulbrinter (PAH) biomarkører, levoglucosan, flygtige organiske kemikalier (VOC) biomarkører, tungmetaller og tobaksrelaterede biomarkører.
Urinbiomarkører vil blive målt hos gravide kvinder ved baseline, 24-28 ugers svangerskab og 32-36 ugers svangerskab, og hos nybagte mødre, når barnet er 24 måneder gammelt.
Biomarkører vil blive målt hos ældre voksne kvinder ved baseline, 3, 6, 9, 12 og 18 måneder efter randomisering.
Biomarkører vil blive målt hos børn i alderen 3, 6, 12 og 24 måneder.
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Baseline, 3, 6, 9, 12 og 18 måneder efter randomisering og barnets 24 måneders alder
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Ændring i biomarkører for tørret blodplet (DBS).
Tidsramme: Baseline, 3, 6, 9, 12 og 18 måneder efter randomisering og ved barnets 24 måneders alder
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De vigtigste biomarkører, der skal måles fra de tørrede blodpletter, er: inflammationsmarkører, endotelmarkører for hjertekarsygdom, oxidative stressmarkører, Hb, HbA1C, tumorassocierede antigenantistoffer, cytochrom P450, p53 tumorassocieret antigen (TAA), lipider, metabolomics, MiRNA, tungmetaller.
DBS-biomarkører vil blive målt hos gravide kvinder ved baseline, 24-28 ugers svangerskab og 32-36 svangerskabsuger og hos nybagte mødre, når barnet er 24 måneder gammelt.
DBS-biomarkører vil blive målt hos ældre voksne kvinder ved baseline, 3, 6, 9, 12 og 18 måneder efter randomisering.
DBS biomarkører vil blive målt hos børn i alderen 3, 6, 12 og 24 måneder.
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Baseline, 3, 6, 9, 12 og 18 måneder efter randomisering og ved barnets 24 måneders alder
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Maternal Perceived Stress Scale (PSS)
Tidsramme: 9 til 18 måneder efter randomisering (3 til 12 måneders alder af barnet)
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Cohen's Perceived Stress Scale (PPS) med 10 elementer vurderer den måde, en person vurderer deres livsbegivenheder som stressende (f.eks. "I den sidste måned, hvor ofte har du følt, at vanskeligheder hobede sig op så højt, at du ikke kunne overkomme dem?" ) (Cohen, 1983).
Svar på Likert-niveau varierede fra 0 (aldrig) til 4 (meget ofte), hvilket betyder, at en høj PPS-score ville resultere i et højt niveau af opfattet stress.
En spansksproget PPS oprettet og testet og fundet gyldig og pålidelig (Vallijo et al., 2018).
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9 til 18 måneder efter randomisering (3 til 12 måneders alder af barnet)
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For tidlig fødsel
Tidsramme: Fødsel
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Herunder for tidlig fødsel og dødfødsel.
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Fødsel
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Husstandens fødevareusikkerhed
Tidsramme: Baseline, 18 måneder efter randomisering
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Husholdningernes fødevareusikkerhed vil blive målt ved hjælp af Food Insecurity Experience Scale (FIES), udviklet og valideret af Food and Agriculture Organisationen (FAO).
FIES-modulet indeholder otte spørgsmål, hver med ja/nej-svarmuligheder, om husstandens adgang til tilstrækkelig mad og er beregnet til at måle tre domæner af fødevareusikkerhed: usikkerhed/angst, fødevaremængde og fødevarekvalitet.
Hvert spørgsmål har værdier på 0/1, som summeres til en mulig samlet score på 0-8.
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Baseline, 18 måneder efter randomisering
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Kostdiversitet - kvinder
Tidsramme: Baseline til 18 måneder efter randomisering
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Diætdiversitet for kvinder vil blive målt ved at bruge spørgeskemaet Minimum Dietary Diversity - Women (MDD-W) fra FAO og FHI 360, som bruger et åbent genkaldelsesformat til at indsamle data om fødevarer og drikkevarer indtaget af respondenten i løbet af den foregående dag og nat .
Svarene vil blive kategoriseret i ti fødevaregrupper, og kvinder, der rapporterer, at de indtager fem eller mere ud af ti fødevaregrupper, vil blive kategoriseret som at opnå minimal diætdiversitet.
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Baseline til 18 måneder efter randomisering
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Hæmoglobin (Hb) koncentration / anæmi - kvinder
Tidsramme: Baseline, 3 og 5 måneder efter randomisering
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Hb vil blive målt fra en enkelt dråbe kapillærblod opnået via fingerprikker ved hjælp af HemoCue® Hb 201system (HemoCue® AB) point-of-care-enhed
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Baseline, 3 og 5 måneder efter randomisering
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Hæmoglobin (Hb) koncentration / anæmi - spædbørn
Tidsramme: 12 og 18 måneder efter randomisering (6 og 12 måneders alderen)
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Hb vil blive målt fra en enkelt dråbe kapillærblod opnået via fingerprikker ved hjælp af HemoCue® Hb 201system (HemoCue® AB) point-of-care-enhed
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12 og 18 måneder efter randomisering (6 og 12 måneders alderen)
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Change in fine particulate matter (PM2.5) exposure
Tidsramme: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Personal monitoring equipment is used to assess exposure to fine particulate matter (PM2.5) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children).
Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old.
Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age.
Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
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Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Change in Carbon monoxide (CO) exposure
Tidsramme: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Personal monitoring equipment is used to assess exposure to carbon monoxide (CO) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children).
Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old.
Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age.
Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
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Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Change in Black carbon (BC) exposure
Tidsramme: Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Personal monitoring equipment is used to assess exposure to black carbon (BC) over a 24-hour period in intervention and control participants (pregnant women, older adult women, and children).
Exposure for pregnant women is measured at baseline, 24-28 weeks gestation, 32-36 weeks gestation, and in Guatemala and India, when the child is 24 months old.
Exposure for the child is measured at 3, 6, 12, 24, 36, 48 and 60 months of age.
Exposure for the older adult women is measured at baseline, 3, 6, 12 and 18 months post-randomization, and in Guatemala and India, when the child is 24 months old.
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Baseline, 3, 6, 9, 12 and 18 months post-randomization, and at 24, 36, 48, 60 months of age of the child
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Messenger Ribonucleic Acid (mRNA) Expression and microRNA in Older Adult Women
Tidsramme: Baseline, 18 months post-randomization
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Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon.
Nasal turbinate brush samples can be collected using a soft cytobrush on each turbinate.
Collection is gentle and causes no discomfort to study participants.
Both samples will be processed in the laboratory according to procedures detailed in the protocol.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Microbiome Operational Taxonomic Units (OTUs) in Older Adult Women
Tidsramme: Baseline, 18 months post-randomization
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For the oral rinse, participants will vigorously rinse their mouth and the rinsates are collected in a centrifuge tube.
The tube is centrifuged and the pellet and supernatant are removed to separate cryovials, labeled and frozen.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Epigenetics (DNA methylation) in Older Adult Women
Tidsramme: Baseline, 18 months post-randomization
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Two buccal cell scrapes will be collected by gently scraping the buccal mucosa on both sides of the mouth with a small plastic collection spoon.
A 5-mL venous blood sample will be collected in an ethylenediaminetetraacetic acid (EDTA) vacutainer tube by standard clinical venipuncture of a cubital vein.
Both samples will be transported and processed in the laboratory according to procedures detailed in the protocol.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Metabolomics and MicroRNA in Older Adult Women
Tidsramme: Baseline, 18 months post-randomization
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A 5-mL venous blood sample will be collected in an EDTA vacutainer tube by standard clinical venipuncture of a cubital vein.
The sample will be transported and processed in the laboratory according to procedures detailed in the protocol.
This will occur in the older adult women in an NCI substudy.
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Baseline, 18 months post-randomization
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Dietary diversity - infants
Tidsramme: 9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
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Minimum dietary diversity for children will be measured using the World Health Organization (WHO) infant and young child feeding questionnaire.
The questionnaire uses a combination of open and closed recall and asks caregivers to report on foods and beverages consumed by the infant or young child during the previous day and night.
Responses will be categorized into eight food groups and infants who consumed five or more out of ten eight food groups will be categorized as achieving minimum dietary diversity.
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9, 12, 15 and 18 months post-randomization (3, 6, 9, and 12 months of age)
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Carotid intima-media thickness (CIMT) Among Older Adult Women During Extended Follow-up
Tidsramme: 24 months of age of the child
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The carotid intima-media thickness test (CIMT) is used to determine the extent of carotid atherosclerotic vascular disease.
The test measures the thickness of the inner two layers of the carotid artery and can detect plaque build up prior to physical symptoms being experienced.
The carotid ultrasound will be performed with a portable ultrasound by trained sonographers.
This outcome is only assessed in Guatemala during the extended follow-up period (after the birth of the household child).
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24 months of age of the child
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Reported Diarrhea in Children
Tidsramme: Up to 12 months after birth
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Reported diarrhea will be extracted from the Monthly Child Health Status Visit case report form.
Each month, the child's caretaker will be administered a survey to obtain information on whether the child under 1 year of age (the HAPIN study index child) or any other child in the home under 5 has experienced WHO-defined diarrhea (defined as three or more loose stools that can take the shape of a container within a 24-hour period) in the past 7 days.
Persistent diarrhea will be defined as 14 or more continuous days of diarrhea.
The presence of blood in the stool will also be noted as an indicator of severity.
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Up to 12 months after birth
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas Clasen, PhD, Emory University
- Ledende efterforsker: Jennifer Peel, PhD, Colorado State University
- Ledende efterforsker: William Checkley, MD PhD, Johns Hopkins School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kearns KA, Naeher LP, McCracken JP, Boyd Barr D, Saikawa E, Hengstermann M, Mollinedo E, Panuwet P, Yakimavets V, Lee GE, Thompson LM. Estimating personal exposures to household air pollution and plastic garbage burning among adolescent girls in Jalapa, Guatemala. Chemosphere. 2024 Jan;348:140705. doi: 10.1016/j.chemosphere.2023.140705. Epub 2023 Nov 17.
- Younger A, Ye W, Alkon A, Harknett K, Kirby MA, Elon L, Lovvorn AE, Wang J, Diaz-Artiga A, McCracken JP, Castanaza Gonzalez A, Alarcon LM, Mukeshimana A, Rosa G, Chiang M, Balakrishnan K, Garg SS, Pillarisetti A, Piedrahita R, Johnson MA, Craik R, Papageorghiou AT, Toenjes A, Williams KN, Underhill LJ, Hartinger SM, Nicolaou L, Chang HH, Naeher LP, Rosenthal J, Checkley W, Peel JL, Clasen TF, Thompson LM; Household Air Pollution Intervention Network (HAPIN) Investigators. Effects of a liquefied petroleum gas stove intervention on stillbirth, congenital anomalies and neonatal mortality: A multi-country household air pollution intervention network trial. Environ Pollut. 2024 Mar 15;345:123414. doi: 10.1016/j.envpol.2024.123414. Epub 2024 Jan 27.
- Pillarisetti A, Ye W, Balakrishnan K, Rosa G, Diaz-Artiga A, Underhill LJ, Steenland K, Peel JL, Kirby MA, McCracken J, Waller L, Chang H, Wang J, Dusabimana E, Ndagijimana F, Sambandam S, Mukhopadhyay K, Kearns KA, Campbell D, Kremer J, Rosenthal J, Ghosh A, Clark M, Checkley W, Clasen T, Naeher L, Piedrahita R, Johnson M. Post-birth exposure contrasts for children during the Household Air Pollution Intervention Network randomized controlled trial. medRxiv [Preprint]. 2023 Jul 6:2023.07.04.23292226. doi: 10.1101/2023.07.04.23292226.
- Simkovich SM, Hossen S, McCollum ED, Toenjes AK, McCracken JP, Thompson LM, Castanaza A, Diaz A, Rosa G, Kirby MA, Mukeshimana A, Myers R, Lenzen PM, Craik R, Jabbarzadeh S, Elon L, Garg SS, Balakrishnan K, Thangavel G, Peel JL, Clasen TF, Davila-Roman VG, Papageorghiou AT, de las Fuentes L, Checkley W; HAPIN Investigators. Lung Ultrasound Protocol and Quality Control of Image Interpretation Using an Adjudication Panel in the Household Air Pollution Intervention Network (HAPIN) Trial. Ultrasound Med Biol. 2023 May;49(5):1194-1201. doi: 10.1016/j.ultrasmedbio.2023.01.005. Epub 2023 Feb 19.
- Williams KN, Quinn A, North H, Wang J, Pillarisetti A, Thompson LM, Diaz-Artiga A, Balakrishnan K, Thangavel G, Rosa G, Ndagijimana F, Underhill LJ, Kirby MA, Puzzolo E, Hossen S, Waller LA, Peel JL, Rosenthal JP, Clasen TF, Harvey SA, Checkley W; HAPIN Investigators. Fidelity and adherence to a liquefied petroleum gas stove and fuel intervention: The multi-country Household Air Pollution Intervention Network (HAPIN) trial. Environ Int. 2023 Sep;179:108160. doi: 10.1016/j.envint.2023.108160. Epub 2023 Aug 19.
- Younger A, Alkon A, Harknett K, Kirby MA, Elon L, Lovvorn AE, Wang J, Ye W, Diaz-Artiga A, McCracken JP, Castanaza Gonzalez A, Monroy Alarcon L, Mukeshimana A, Rosa G, Chiang M, Balakrishnan K, Garg SS, Pillarisetti A, Piedrahita R, Johnson M, Craik R, Papageorghiou AT, Toenjes A, Quinn A, Williams KN, Underhill L, Chang HH, Naeher LP, Rosenthal J, Checkley W, Peel JL, Clasen TF, Thompson LM; HAPIN investigators. Effects of a LPG stove and fuel intervention on adverse maternal outcomes: A multi-country randomized controlled trial conducted by the Household Air Pollution Intervention Network (HAPIN). Environ Int. 2023 Aug;178:108059. doi: 10.1016/j.envint.2023.108059. Epub 2023 Jun 28.
- Checkley W, Hossen S, Rosa G, Thompson LM, McCracken JP, Diaz-Artiga A, Balakrishnan K, Simkovich SM, Underhill LJ, Nicolaou L, Hartinger SM, Davila-Roman VG, Kirby MA, Clasen TF, Rosenthal J, Peel JL, On Behalf Of Household Air Pollution Intervention Network Hapin Investigators. Facing the Realities of Pragmatic Design Choices in Environmental Health Studies: Experiences from the Household Air Pollution Intervention Network Trial. Int J Environ Res Public Health. 2022 Mar 23;19(7):3790. doi: 10.3390/ijerph19073790.
- Hennessee I, Kirby MA, Misago X, Mupfasoni J, Clasen T, Kitron U, Rosenthal JP, Hakizimana E. Assessing the Effects of Cooking Fuels on Anopheles Mosquito Behavior: An Experimental Study in Rural Rwanda. Am J Trop Med Hyg. 2022 Feb 21;106(4):1196-1208. doi: 10.4269/ajtmh.21-0997. Print 2022 Apr 6.
- Johnson M, Pillarisetti A, Piedrahita R, Balakrishnan K, Peel JL, Steenland K, Underhill LJ, Rosa G, Kirby MA, Diaz-Artiga A, McCracken J, Clark ML, Waller L, Chang HH, Wang J, Dusabimana E, Ndagijimana F, Sambandam S, Mukhopadhyay K, Kearns KA, Campbell D, Kremer J, Rosenthal JP, Checkley W, Clasen T, Naeher L; the Household Air Pollution Intervention Network (HAPIN) Trial Investigators. Exposure Contrasts of Pregnant Women during the Household Air Pollution Intervention Network Randomized Controlled Trial. Environ Health Perspect. 2022 Sep;130(9):97005. doi: 10.1289/EHP10295. Epub 2022 Sep 16.
- Kaufman JD. Invited Perspective: A Critical Part of a Real-World Environmental Health Trial Is to Demonstrate That the Intervention Reduced Exposure. Environ Health Perspect. 2022 Sep;130(9):91304. doi: 10.1289/EHP11697. Epub 2022 Sep 16. No abstract available.
- Rajamani KD, Sambandam S, Mukhopadhyay K, Puttaswamy N, Thangavel G, Natesan D, Ramasamy R, Sendhil S, Natarajan A, Aravindalochan V, Pillarisetti A, Johnson M, Rosenthal J, Steenland K, Piedhrahita R, Peel J, Clark ML, Boyd Barr D, Rajkumar S, Young B, Jabbarzadeh S, Rosa G, Kirby M, Underhill LJ, Diaz-Artiga A, Lovvorn A, Checkley W, Clasen T, Balakrishnan K. Visualizing Field Data Collection Procedures of Exposure and Biomarker Assessments for the Household Air Pollution Intervention Network Trial in India. J Vis Exp. 2022 Dec 23;(190). doi: 10.3791/64144.
- Ye W, Thangavel G, Pillarisetti A, Steenland K, Peel JL, Balakrishnan K, Jabbarzadeh S, Checkley W, Clasen T; HAPIN Investigators. Association between personal exposure to household air pollution and gestational blood pressure among women using solid cooking fuels in rural Tamil Nadu, India. Environ Res. 2022 May 15;208:112756. doi: 10.1016/j.envres.2022.112756. Epub 2022 Jan 20.
- Ye W, Steenland K, Quinn A, Liao J, Balakrishnan K, Rosa G, Ndagijimana F, Ntivuguruzwa JD, Thompson LM, McCracken JP, Diaz-Artiga A, Rosenthal JP, Papageorghiou A, Davila-Roman VG, Pillarisetti A, Johnson M, Wang J, Nicolaou L, Checkley W, Peel JL, Clasen TF; Household Air Pollution Intervention Network (HAPIN) trial Investigators. Effects of a Liquefied Petroleum Gas Stove Intervention on Gestational Blood Pressure: Intention-to-Treat and Exposure-Response Findings From the HAPIN Trial. Hypertension. 2022 Aug;79(8):1887-1898. doi: 10.1161/HYPERTENSIONAHA.122.19362. Epub 2022 Jun 16.
- Hengstermann M, Diaz-Artiga A, Otzoy-Sucuc R, Laura Maria Ruiz-Aguilar A, Thompson LM; HAPIN Investigators. Developing Visual Messages to Support Liquefied Petroleum Gas Use in Intervention Homes in the Household Air Pollution Intervention Network (HAPIN) Trial in Rural Guatemala. Health Educ Behav. 2021 Oct;48(5):651-669. doi: 10.1177/1090198121996280. Epub 2021 Mar 18.
- Liao J, Kirby MA, Pillarisetti A, Piedrahita R, Balakrishnan K, Sambandam S, Mukhopadhyay K, Ye W, Rosa G, Majorin F, Dusabimana E, Ndagijimana F, McCracken JP, Mollinedo E, de Leon O, Diaz-Artiga A, Thompson LM, Kearns KA, Naeher L, Rosenthal J, Clark ML, Steenland K, Waller LA, Checkley W, Peel JL, Clasen T, Johnson M; HAPIN Investigators. LPG stove and fuel intervention among pregnant women reduce fine particle air pollution exposures in three countries: Pilot results from the HAPIN trial. Environ Pollut. 2021 Dec 15;291:118198. doi: 10.1016/j.envpol.2021.118198. Epub 2021 Sep 21.
- Quinn AK, Williams KN, Thompson LM, Harvey SA, Piedrahita R, Wang J, Quinn C, Pillarisetti A, McCracken JP, Rosenthal JP, Kirby MA, Diaz Artiga A, Thangavel G, Rosa G, Miranda JJ, Checkley W, Peel JL, Clasen TF. Fidelity and Adherence to a Liquefied Petroleum Gas Stove and Fuel Intervention during Gestation: The Multi-Country Household Air Pollution Intervention Network (HAPIN) Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Nov 29;18(23):12592. doi: 10.3390/ijerph182312592.
- Simkovich SM, Underhill LJ, Kirby MA, Crocker ME, Goodman D, McCracken JP, Thompson LM, Diaz-Artiga A, Castanaza-Gonzalez A, Garg SS, Balakrishnan K, Thangavel G, Rosa G, Peel JL, Clasen TF, McCollum ED, Checkley W; HAPIN Investigators. Resources and Geographic Access to Care for Severe Pediatric Pneumonia in Four Resource-limited Settings. Am J Respir Crit Care Med. 2022 Jan 15;205(2):183-197. doi: 10.1164/rccm.202104-1013OC.
- Barr DB, Puttaswamy N, Jaacks LM, Steenland K, Rajkumar S, Gupton S, Ryan PB, Balakrishnan K, Peel JL, Checkley W, Clasen T, Clark ML; (HAPIN Investigative Team). Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial. Environ Health Perspect. 2020 Apr;128(4):47010. doi: 10.1289/EHP5751. Epub 2020 Apr 29.
- Burrowes VJ, Piedrahita R, Pillarisetti A, Underhill LJ, Fandino-Del-Rio M, Johnson M, Kephart JL, Hartinger SM, Steenland K, Naeher L, Kearns K, Peel JL, Clark ML, Checkley W; HAPIN Investigators. Comparison of next-generation portable pollution monitors to measure exposure to PM2.5 from household air pollution in Puno, Peru. Indoor Air. 2020 May;30(3):445-458. doi: 10.1111/ina.12638. Epub 2020 Jan 23.
- Clasen T, Checkley W, Peel JL, Balakrishnan K, McCracken JP, Rosa G, Thompson LM, Barr DB, Clark ML, Johnson MA, Waller LA, Jaacks LM, Steenland K, Miranda JJ, Chang HH, Kim DY, McCollum ED, Davila-Roman VG, Papageorghiou A, Rosenthal JP; HAPIN Investigators. Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution. Environ Health Perspect. 2020 Apr;128(4):47008. doi: 10.1289/EHP6407. Epub 2020 Apr 29.
- Crocker ME, Hossen S, Goodman D, Simkovich SM, Kirby M, Thompson LM, Rosa G, Garg SS, Thangavel G, McCollum ED, Peel J, Clasen T, Checkley W; HAPIN Investigators. Effects of high altitude on respiratory rate and oxygen saturation reference values in healthy infants and children younger than 2 years in four countries: a cross-sectional study. Lancet Glob Health. 2020 Mar;8(3):e362-e373. doi: 10.1016/S2214-109X(19)30543-1.
- Johnson MA, Steenland K, Piedrahita R, Clark ML, Pillarisetti A, Balakrishnan K, Peel JL, Naeher LP, Liao J, Wilson D, Sarnat J, Underhill LJ, Burrowes V, McCracken JP, Rosa G, Rosenthal J, Sambandam S, de Leon O, Kirby MA, Kearns K, Checkley W, Clasen T; HAPIN Investigators. Air Pollutant Exposure and Stove Use Assessment Methods for the Household Air Pollution Intervention Network (HAPIN) Trial. Environ Health Perspect. 2020 Apr;128(4):47009. doi: 10.1289/EHP6422. Epub 2020 Apr 29.
- Puttaswamy N, Saidam S, Rajendran G, Arumugam K, Gupton S, Williams EW, Johnson CL, Panuwet P, Rajkumar S, Clark ML, Peel JL, Checkley W, Clasen T, Balakrishnan K, Barr DB. Cross-validation of biomonitoring methods for polycyclic aromatic hydrocarbon metabolites in human urine: Results from the formative phase of the Household Air Pollution Intervention Network (HAPIN) trial in India. J Chromatogr B Analyt Technol Biomed Life Sci. 2020 Oct 1;1154:122284. doi: 10.1016/j.jchromb.2020.122284. Epub 2020 Jul 29.
- Sambandam S, Mukhopadhyay K, Sendhil S, Ye W, Pillarisetti A, Thangavel G, Natesan D, Ramasamy R, Natarajan A, Aravindalochanan V, Vinayagamoorthi A, Sivavadivel S, Uma Maheswari R, Balakrishnan L, Gayatri S, Nargunanathan S, Madhavan S, Puttaswamy N, Garg SS, Quinn A, Rosenthal J, Johnson M, Liao J, Steenland K, Piedhrahita R, Peel J, Checkley W, Clasen T, Balakrishnan K. Exposure contrasts associated with a liquefied petroleum gas (LPG) intervention at potential field sites for the multi-country household air pollution intervention network (HAPIN) trial in India: results from pilot phase activities in rural Tamil Nadu. BMC Public Health. 2020 Nov 26;20(1):1799. doi: 10.1186/s12889-020-09865-1.
- Simkovich SM, Underhill LJ, Kirby MA, Goodman D, Crocker ME, Hossen S, McCracken JP, de Leon O, Thompson LM, Garg SS, Balakrishnan K, Thangavel G, Rosa G, Peel JL, Clasen TF, McCollum ED, Checkley W. Design and conduct of facility-based surveillance for severe childhood pneumonia in the Household Air Pollution Intervention Network (HAPIN) trial. ERJ Open Res. 2020 Mar 23;6(1):00308-2019. doi: 10.1183/23120541.00308-2019. eCollection 2020 Jan.
- Williams KN, Thompson LM, Sakas Z, Hengstermann M, Quinn A, Diaz-Artiga A, Thangavel G, Puzzolo E, Rosa G, Balakrishnan K, Peel J, Checkley W, Clasen TF, Miranda JJ, Rosenthal JP, Harvey SA; Household Air Pollution Intervention Network (HAPIN) trial Investigators; HAPIN Investigators. Designing a comprehensive behaviour change intervention to promote and monitor exclusive use of liquefied petroleum gas stoves for the Household Air Pollution Intervention Network (HAPIN) trial. BMJ Open. 2020 Sep 29;10(9):e037761. doi: 10.1136/bmjopen-2020-037761.
- Wilson DL, Williams KN, Pillarisetti A. 2020. An Integrated Sensor Data Logging, Survey, and Analytics Platform for Field Research and Its Application in HAPIN, a Multi-Center Household Energy Intervention Trial. Sustainability. 2020; 12 (5): 1805. doi:10.3390/su12051805.
- Goodman D, Crocker ME, Pervaiz F, McCollum ED, Steenland K, Simkovich SM, Miele CH, Hammitt LL, Herrera P, Zar HJ, Campbell H, Lanata CF, McCracken JP, Thompson LM, Rosa G, Kirby MA, Garg S, Thangavel G, Thanasekaraan V, Balakrishnan K, King C, Clasen T, Checkley W; HAPIN Investigators. Challenges in the diagnosis of paediatric pneumonia in intervention field trials: recommendations from a pneumonia field trial working group. Lancet Respir Med. 2019 Dec;7(12):1068-1083. doi: 10.1016/S2213-2600(19)30249-8. Epub 2019 Oct 4.
- Quinn AK, Williams K, Thompson LM, Rosa G, Diaz-Artiga A, Thangavel G, Balakrishnan K, Miranda JJ, Rosenthal JP, Clasen TF, Harvey SA; HAPIN Investigators. Compensating control participants when the intervention is of significant value: experience in Guatemala, India, Peru and Rwanda. BMJ Glob Health. 2019 Aug 21;4(4):e001567. doi: 10.1136/bmjgh-2019-001567. eCollection 2019.
- Steenland K, Pillarisetti A, Kirby M, Peel J, Clark M, Checkley W, Chang HH, Clasen T. Modeling the potential health benefits of lower household air pollution after a hypothetical liquified petroleum gas (LPG) cookstove intervention. Environ Int. 2018 Feb;111:71-79. doi: 10.1016/j.envint.2017.11.018. Epub 2017 Nov 26.
- Checkley W, Thompson LM, Sinharoy SS, Hossen S, Moulton LH, Chang HH, Waller L, Steenland K, Rosa G, Mukeshimana A, Ndagijimana F, McCracken JP, Diaz-Artiga A, Balakrishnan K, Garg SS, Thangavel G, Aravindalochanan V, Hartinger SM, Chiang M, Kirby MA, Papageorghiou AT, Ramakrishnan U, Williams KN, Nicolaou L, Johnson M, Pillarisetti A, Rosenthal J, Underhill LJ, Wang J, Jabbarzadeh S, Chen Y, Davila-Roman VG, Naeher LP, McCollum ED, Peel JL, Clasen TF; HAPIN Investigators. Effects of Cooking with Liquefied Petroleum Gas or Biomass on Stunting in Infants. N Engl J Med. 2024 Jan 4;390(1):44-54. doi: 10.1056/NEJMoa2302687.
- McCollum ED, McCracken JP, Kirby MA, Grajeda LM, Hossen S, Moulton LH, Simkovich SM, Goodman-Palmer D, Rosa G, Mukeshimana A, Balakrishnan K, Thangavel G, Garg SS, Castanaza A, Thompson LM, Diaz-Artiga A, Papageorghiou AT, Davila-Roman VG, Underhill LJ, Hartinger SM, Williams KN, Nicolaou L, Chang HH, Lovvorn AE, Rosenthal JP, Pillarisetti A, Ye W, Naeher LP, Johnson MA, Waller LA, Jabbarzadeh S, Wang J, Chen Y, Steenland K, Clasen TF, Peel JL, Checkley W; HAPIN Investigators. Liquefied Petroleum Gas or Biomass Cooking and Severe Infant Pneumonia. N Engl J Med. 2024 Jan 4;390(1):32-43. doi: 10.1056/NEJMoa2305681.
- Balakrishnan K, Steenland K, Clasen T, Chang H, Johnson M, Pillarisetti A, Ye W, Naeher LP, Diaz-Artiga A, McCracken JP, Thompson LM, Rosa G, Kirby MA, Thangavel G, Sambandam S, Mukhopadhyay K, Puttaswamy N, Aravindalochanan V, Garg S, Ndagijimana F, Hartinger S, Underhill LJ, Kearns KA, Campbell D, Kremer J, Waller L, Jabbarzadeh S, Wang J, Chen Y, Rosenthal J, Quinn A, Papageorghiou AT, Ramakrishnan U, Howards PP, Checkley W, Peel JL; HAPIN Investigators. Exposure-response relationships for personal exposure to fine particulate matter (PM2.5), carbon monoxide, and black carbon and birthweight: an observational analysis of the multicountry Household Air Pollution Intervention Network (HAPIN) trial. Lancet Planet Health. 2023 May;7(5):e387-e396. doi: 10.1016/S2542-5196(23)00052-9.
- Clasen TF, Chang HH, Thompson LM, Kirby MA, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Steenland K, Younger A, Aravindalochanan V, Barr DB, Castanaza A, Chen Y, Chiang M, Clark ML, Garg S, Hartinger S, Jabbarzadeh S, Johnson MA, Kim DY, Lovvorn AE, McCollum ED, Monroy L, Moulton LH, Mukeshimana A, Mukhopadhyay K, Naeher LP, Ndagijimana F, Papageorghiou A, Piedrahita R, Pillarisetti A, Puttaswamy N, Quinn A, Ramakrishnan U, Sambandam S, Sinharoy SS, Thangavel G, Underhill LJ, Waller LA, Wang J, Williams KN, Rosenthal JP, Checkley W, Peel JL; HAPIN Investigators. Liquefied Petroleum Gas or Biomass for Cooking and Effects on Birth Weight. N Engl J Med. 2022 Nov 10;387(19):1735-1746. doi: 10.1056/NEJMoa2206734. Epub 2022 Oct 10.
- Simkovich SM, Thompson LM, Clark M, Balakrishnan K, Bussalleu A, Checkley W, Clasen T, Davila-Roman V, Diaz-Artiga A, de las Fuentes L, Harvey S, Kirby M, Lovvorn A, McCollum E, Peel J, Quinn A, Rosa G, Underhill L, Williams K, Young B, Rosenthal J. A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic. Res Sq [Preprint]. 2020 Nov 12:rs.3.rs-103997. doi: 10.21203/rs.3.rs-103997/v1.
- Nicolaou L, Underhill L, Hossen S, Simkovich S, Thangavel G, Rosa G, McCracken JP, Davila-Roman V, de las Fuentes L, Quinn AK, Clark M, Diaz A, Pillarisetti A, Steenland K, Waller LA, Jabbarzadeh S, Peel JL, Checkley W; HAPIN Investigators. Cross-sectional analysis of the association between personal exposure to household air pollution and blood pressure in adult women: Evidence from the multi-country Household Air Pollution Intervention Network (HAPIN) trial. Environ Res. 2022 Nov;214(Pt 4):114121. doi: 10.1016/j.envres.2022.114121. Epub 2022 Aug 24.
- Davila-Roman VG, Toenjes AK, Meyers RM, Lenzen PM, Simkovich SM, Herrera P, Fung E, Papageorghiou AT, Craik R, McCracken JP, Thompson LM, Balakrishnan K, Rosa G, Peel J, Clasen TF, Hossen S, Checkley W, de las Fuentes L; HAPIN Investigators. Ultrasound Core Laboratory for the Household Air Pollution Intervention Network Trial: Standardized Training and Image Management for Field Studies Using Portable Ultrasound in Fetal, Lung, and Vascular Evaluations. Ultrasound Med Biol. 2021 Jun;47(6):1506-1513. doi: 10.1016/j.ultrasmedbio.2021.02.015. Epub 2021 Apr 1.
- Simkovich SM, Thompson LM, Clark ML, Balakrishnan K, Bussalleu A, Checkley W, Clasen T, Davila-Roman VG, Diaz-Artiga A, Dusabimana E, de las Fuentes L, Harvey S, Kirby MA, Lovvorn A, McCollum ED, Mollinedo EE, Peel JL, Quinn A, Rosa G, Underhill LJ, Williams KN, Young BN, Rosenthal J; HAPIN Investigators. A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings. BMC Med Res Methodol. 2021 Apr 12;21(1):68. doi: 10.1186/s12874-021-01232-x.
- Liao J, McCracken JP, Piedrahita R, Thompson L, Mollinedo E, Canuz E, De Leon O, Diaz-Artiga A, Johnson M, Clark M, Pillarisetti A, Kearns K, Naeher L, Steenland K, Checkley W, Peel J, Clasen TF; HAPIN investigators. The use of bluetooth low energy Beacon systems to estimate indirect personal exposure to household air pollution. J Expo Sci Environ Epidemiol. 2020 Nov;30(6):990-1000. doi: 10.1038/s41370-019-0172-z. Epub 2019 Sep 26.
- Pillarisetti A, Ye W, Peel JL, Chang H, Underhill LJ, Balakrishnan K, Diaz-Artiga A, McCracken JP, Rosa G, Thompson LM, Aravindalochanan V, Boyd Barr D, Chen Y, Chiang M, Clark ML, Davila-Roman V, Jabbarzadeh S, Johnson MA, Kirby MA, Lovvorn AE, Naeher LP, Ndagijimana F, Piedrahita R, Puttaswamy N, Waller LA, Wang J, Williams KN, Nicolaou L, Checkley W, Clasen TF, Rosenthal JP, Steenland K; HAPIN Investigators. Household air pollution and blood pressure among adult women participants of the Household Air Pollution Intervention Network Trial: An exposure-response analysis. Environ Res. 2025 Nov 15;285(Pt 5):122570. doi: 10.1016/j.envres.2025.122570. Epub 2025 Aug 12.
- Sivalogan K, Stein AD, Thompson LM, Wang J, Diaz-Artiga A, Aravindalochanan V, Jabbarzadeh S, Nicolaou L, Williams KN, Balakrishnan K, Peel JL, Checkley W, Clasen T, Sinharoy SS; HAPIN investigators. Provision of a liquefied petroleum gas cookstove and fuel during pregnancy and infancy and linear growth trajectories between birth and 12 months: evidence from the multi-center Household Air Pollution Intervention Network (HAPIN) trial. medRxiv [Preprint]. 2025 Jun 6:2025.06.05.25329099. doi: 10.1101/2025.06.05.25329099.
- Quinn A, Hengstermann M, Diaz-Artiga A, Pillarisetti A, Clark M, Ruiz-Aguilar L, Ndagijimana F, McCracken JP, Rosa G, Checkley W, Peel J, Clasen TF, Thompson L; HAPIN Investigators. Development of personal air pollution exposure report-back materials to Household Air Pollution Intervention Network (HAPIN) trial participants in Guatemala and Rwanda: a qualitative study. BMJ Glob Health. 2025 May 15;10(5):e017672. doi: 10.1136/bmjgh-2024-017672.
- Raheel H, Sinharoy S, Diaz-Artiga A, Garg SS, Pillarisetti A, Balakrishnan K, Chiang M, Lovvorn A, Kirby M, Ramakrishnan U, Jabbarzadeh S, Mukeshimana A, Johnson M, McCracken JP, Naeher LP, Rosa G, Wang J, Rosenthal J, Checkley W, Clasen TF, Peel JL, Thompson LM; Household Air Pollution Intervention Network (HAPIN) investigators. Effects of a liquefied petroleum gas stove and fuel intervention on head circumference and length at birth: A multi-country household air pollution intervention network (HAPIN) trial. Environ Int. 2025 Jan;195:109211. doi: 10.1016/j.envint.2024.109211. Epub 2024 Dec 24.
- Patil SS, Puttaswamy N, Cardenas A, Barr DB, Ghosh S, Balakrishnan K. Protocol for CARES-HAPIN: an ambidirectional cohort study on exposure to environmental tobacco smoke and risk of early childhood caries. BMJ Open. 2024 May 15;14(5):e083874. doi: 10.1136/bmjopen-2024-083874.
- Sivalogan K, Liang D, Accardi C, Diaz-Artiga A, Hu X, Mollinedo E, Ramakrishnan U, Teeny SN, Tran V, Clasen TF, Thompson LM, Sinharoy SS. Human Milk Composition Is Associated with Maternal Body Mass Index in a Cross-Sectional, Untargeted Metabolomics Analysis of Human Milk from Guatemalan Mothers. Curr Dev Nutr. 2024 Apr 10;8(5):102144. doi: 10.1016/j.cdnut.2024.102144. eCollection 2024 May.
- Checkley W, Thompson LM, Hossen S, Nicolaou L, Williams KN, Hartinger SM, Chiang M, Balakrishnan K, Garg SS, Thangavel G, Aravindalochanan V, Rosa G, Mukeshimana A, Ndagijimana F, McCracken JP, Diaz-Artiga A, Sinharoy SS, Waller L, Wang J, Jabbarzadeh S, Chen Y, Steenland K, Kirby MA, Ramakrishnan U, Johnson M, Pillarisetti A, McCollum ED, Craik R, Ohuma EO, Davila-Roman VG, de las Fuentes L, Simkovich SM, Peel JL, Clasen TF, Papageorghiou AT; Household Air Pollution Intervention Network (HAPIN) Investigators. Cooking with liquefied petroleum gas or biomass and fetal growth outcomes: a multi-country randomised controlled trial. Lancet Glob Health. 2024 May;12(5):e815-e825. doi: 10.1016/S2214-109X(24)00033-0.
- Mollinedo E, McCracken JP, Johnson M, Piedrahita R, Pillarisetti A, Waller LA, Wang J, Thompson LM, Diaz-Artiga A, de Leon O, Ramirez A, Polanco A, Campbell D, Kearns KA, Kremer J, Nicolaou L, Clark ML, Balakrishnan K, Rosa G, Peel JL, Checkley W, Clasen TF, Naeher LP. Comparing Performance and Reliability of Collocated Enhanced Children's MicroPEM (ECM) on Gravimetric and Nephelometric PM2.5 Personal Exposure Samples in Field Measurements in Rural Guatemala. Indoor Air. 2025;2025:8812602. doi: 10.1155/ina/8812602. Epub 2025 Jan 2.
- Sivalogan K, Stein AD, Thompson LM, Wang J, Diaz-Artiga A, Aravindalochanan V, Jabbarzadeh S, Lovvorn AE, Ndagijimana F, Nicolaou L, Williams KN, Balakrishnan K, Peel JL, Checkley W, Clasen T, Sinharoy SS; HAPIN investigators paragraph sign. Provision of a liquefied petroleum gas cookstove and fuel during pregnancy and infancy and linear growth trajectories between birth and 12 months: Evidence from the multi-center Household Air Pollution Intervention Network (HAPIN) trial. PLOS Glob Public Health. 2025 Dec 31;5(12):e0004831. doi: 10.1371/journal.pgph.0004831. eCollection 2025.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2017
Primær færdiggørelse (Faktiske)
30. juni 2025
Studieafslutning (Faktiske)
30. juni 2025
Datoer for studieregistrering
Først indsendt
17. oktober 2016
Først indsendt, der opfyldte QC-kriterier
24. oktober 2016
Først opslået (Anslået)
26. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00089799
- 1UM1HL134590-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Liquefied petroleum gas (LPG) cookstove
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