- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02944682
Husholdningers luftforurensning og helse: En flerlandlig LPG-intervensjonsforsøk (HAPIN)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Globalt er nesten 3 milliarder mennesker avhengige av fast brensel for matlaging og oppvarming, de aller fleste i lav- og mellominntektsland (LMICs). Den resulterende husholdningenes luftforurensning (HAP) er den tredje ledende risikofaktoren i den globale sykdomsbyrden i 2010, og står for anslagsvis 4,3 millioner dødsfall årlig, hovedsakelig blant kvinner og små barn. Tidligere intervensjoner har gitt renere biomassebaserte kokeovner, men har ikke klart å redusere eksponeringen for nivåer som gir meningsfulle helseforbedringer. Det har ikke vært noen storskala feltforsøk med kokeovner med flytende petroleumsgass (LPG), sannsynligvis den reneste skalerbare intervensjonen.
Målet med denne studien er å gjennomføre et randomisert kontrollert forsøk med distribusjon av LPG-ovner og drivstoff i 3200 husstander i fire LMIC-er (India, Guatemala, Peru og Rwanda) for å levere strenge bevis angående potensielle helsegevinster gjennom hele levetiden. Hvert intervensjonssted vil rekruttere 800 gravide kvinner (i alderen 18-34 år, 9 - <20 svangerskapsuker), og vil tilfeldig tildele halvparten av husstandene sine til å motta LPG-ovner og en 18-måneders forsyning med LPG. Kontrollhusholdninger forventes å fortsette å lage mat primært med fast biomassebrensel, og vil motta kompensasjon basert på et enhetlig sett med prinsipper for hele prøveperioden, tilpasset hvert sted basert på formativ forskning. Moren vil følges sammen med barnet sitt til barnet er 1 år. I husholdninger med en andre, ikke-gravid eldre voksen kvinne (i alderen 40 til <80 år) vil forskerne også melde seg inn og følge henne i løpet av den 18-måneders oppfølgingsperioden for å vurdere utfall av hjerte-lunge-, metabolisme og kreft. For å optimalisere bruken av intervensjon vil forskerne implementere atferdsendringsstrategier. Denne studien vil vurdere bruk av komfyr, gjennomføre gjentatte personlige eksponeringsvurderinger for HAP (PM2.5, svart karbon, karbonmonoksid), og samle inn tørkede blodflekker og urinprøver for biomarkøranalyse og lagring av bioprøver på alle deltakere på flere tidspunkter. De primære utfallene er lav fødselsvekt, alvorlig forekomst av lungebetennelse og svemming av barnet, og blodtrykk hos den eldre voksne kvinnen. Sekundære utfall inkluderer prematur fødsel og utvikling hos barnet, mors blodtrykk under svangerskapet og endotelfunksjon, respirasjonssvikt, åreforkalkning, kreftfremkallende metabolitter og livskvalitet hos den eldre voksne kvinnen.
Denne studien vil ta for seg følgende spesifikke mål: (1) ved hjelp av en intent-to-treat-analyse, bestemme effekten av en randomisert LPG-ovn og brenselintervensjon på helsen i fire forskjellige LMIC-populasjoner ved å bruke en felles protokoll; (2) bestemme eksponering-respons-relasjonene for HAP og helseutfall; og (3) bestemme sammenhenger mellom LPG-intervensjon og både målrettede og utforskende biomarkører for eksponering/helseeffekter.
Denne studien vil gi bevis, inkludert kostnader og implementeringsstrategier, for å informere nasjonale og globale retningslinjer for oppskalering av LPG-ovner blant sårbare befolkninger. Til syvende og sist vil dette legge til rette for dypere diskusjoner på policynivå, samt identifisere krav for å initiere og opprettholde HAP-intervensjoner globalt.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
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, India, 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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier for gravide:
- Bekreftet graviditet (hCG positiv blod- eller urinprøve)
- I alderen 18 til <35 år (via egenmelding)
- Bruker hovedsakelig biomasseovn
- Bor i studieområdet
- 9 - <20 ukers svangerskap bekreftet med ultralyd
- Singleton graviditet (ett foster)
- Levedyktig foster med normal føtal hjertefrekvens (120-180 slag per minutt) på tidspunktet for ultralyd
- Fortsatt graviditet på randomiseringstidspunktet bekreftet ved egenrapportering
- Godtar å delta med informert samtykke
Ekskluderingskriterier for gravide:
- Røyker for tiden sigaretter eller andre tobakksprodukter
- Planer om å flytte permanent utenfor studieområdet i løpet av de neste 12 månedene
- Bruker hovedsakelig LPG-ovn, eller vil sannsynligvis bruke LPG hovedsakelig i nær fremtid
Inkluderingskriterier for eldre kvinne i samme husholdning:
- I alderen 40 til <80 år (via egenmelding)
Ekskluderingskriterier for eldre kvinne i samme husholdning:
- Røyker for tiden sigaretter eller andre tobakksprodukter
- Gravid (ved egenmelding)
- Planlegger å flytte ut av sin nåværende husholdning i løpet av de neste 12 månedene
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Kokeovn for flytende petroleumsgass
Deltakere randomisert til den eksperimentelle armen vil motta en kokeovn for flytende petroleumsgass (LPG) og 18 måneders forsyning med 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 inngripen: Kontroll
Deltakerne i kontrollgruppen vil ikke motta en ovn for flytende petroleumsgass (LPG) og vil fortsette å bruke tradisjonelle tilberedningsmetoder (åpen ild eller tradisjonelle ovner), eller tilberedningsmetoden de velger.
Kontrollhusholdninger vil motta kompensasjon basert på et enhetlig sett med prinsipper for hele prøveperioden, tilpasset hvert nettsted basert på formativ forskning.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
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Prematur fødsel
Tidsramme: Opptil 5 måneder (innen 24 timer etter fødselen, 3-5 måneder etter randomisering)
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Prematur fødsel er definert som fødsel av et levende spedbarn før 37 fullførte svangerskapsuker.
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Opptil 5 måneder (innen 24 timer etter fødselen, 3-5 måneder etter randomisering)
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Sykehusinnleggelse for luftveissykdom
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av sykehusinnleggelser for en luftveissykdom i løpet av det første leveåret.
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Inntil 12 måneder etter fødselen
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WHO ikke-alvorlig lungebetennelse
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av ikke-alvorlig lungebetennelse fra WHO (2014-definisjon og 2013-definisjon) i løpet av det første leveåret.
Tilfeller av lungebetennelse registreres når barn kommer til HAPIN helseinstitusjoner med luftveissymptomer.
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Inntil 12 måneder etter fødselen
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WHO alvorlig lungebetennelse
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av ikke-alvorlig lungebetennelse fra WHO (2014-definisjon og 2013-definisjon) i løpet av det første leveåret.
Tilfeller av lungebetennelse registreres når barn kommer til HAPIN helseinstitusjoner med luftveissymptomer.
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Inntil 12 måneder etter fødselen
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WHO Pocket Book Ikke-alvorlig lungebetennelse
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av ikke-alvorlig lungebetennelse fra WHO i løpet av det første leveåret, som definert i den andre utgaven av "Lommebok for sykehusomsorg for barn" (2013).
Tilfeller av lungebetennelse registreres når barn kommer til HAPIN helseinstitusjoner med luftveissymptomer.
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Inntil 12 måneder etter fødselen
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WHO Pocket Book Alvorlig lungebetennelse
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av WHOs alvorlige lungebetennelse i løpet av det første leveåret, som definert i andre utgave av "Lommebok for sykehusomsorg for barn" (2013).
Tilfeller av lungebetennelse registreres når barn kommer til HAPIN helseinstitusjoner med luftveissymptomer.
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Inntil 12 måneder etter fødselen
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Hypoksemisk lungebetennelse
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av hypoksemisk lungebetennelse i løpet av det første leveåret.
Tilfeller av lungebetennelse registreres når barn kommer til HAPIN helseinstitusjoner med luftveissymptomer.
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Inntil 12 måneder etter fødselen
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Ultralyd eller røntgen lungebetennelse
Tidsramme: Inntil 12 måneder etter fødselen
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Kumulativ forekomst av lungeultralyd eller røntgenbilde lungebetennelse i løpet av det første leveåret.
Tilfeller av lungebetennelse registreres når barn kommer til HAPIN helseinstitusjoner med luftveissymptomer.
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Inntil 12 måneder etter fødselen
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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 |
Tiltaksbeskrivelse |
Tidsramme |
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Spontanabort
Tidsramme: Baseline gjennom 20 ukers svangerskap
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Fosterdød før 19 uker 6 dager.
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Baseline gjennom 20 ukers svangerskap
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Tidlig prematur fødsel
Tidsramme: Fødsel
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Fødsler under 34 uker fullførte svangerskapet, blant alle levendefødte.
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Fødsel
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Dødfødsel
Tidsramme: Frem til fødselen
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Eventuelle fosterdødsfall som inntreffer ved eller etter 20 ukers svangerskap ELLER angitt på skjemaet for alvorlige bivirkninger ELLER på skjemaet for gravid kvinnes medisinske historie ELLER på verbal obduksjonsskjema.
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Frem til fødselen
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Neonatal død
Tidsramme: Fødsel gjennom 28 dager
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Død mellom fødsel og 28 dager.
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Fødsel gjennom 28 dager
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Barnets lungefunksjon
Tidsramme: 36, 48 og 60 måneder
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Lungefunksjonsmålinger vil bli utført ved bruk av tvungen oscillasjonsteknikk (FOT) med Tremoflo C-100-enheten med engangsmunnstykker.
FOT er en teknikk som kan identifisere tidlige endringer i luftveiene.
FOT-enheten måler forholdet mellom eksternt påførte trykkbølger og den resulterende luftstrømmen for å måle respirasjonsimpedansen.
Verdier produsert ved høye frekvenser tilsvarer de proksimale og store luftveiene, og verdier produsert ved lave frekvenser tilsvarer distale og små luftveier.
Denne målingen vil bli utført på barn i Guatemala.
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36, 48 og 60 måneder
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Endring i urinbiomarkører
Tidsramme: Baseline, 3, 6, 9, 12 og 18 måneder etter randomisering og 24 måneders alder av barnet
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Biomarkører for flere eksponeringer vil bli målt: 3-OH-kotinin, 4-(metylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), levoglucosan, 8OH-deoksyguanosin (8OHdG) og metabolitter av flyktige organiske kjemikalier (VOC). .
Eksponeringsbiomarkører (spesielt for barn hvis urin kan være begrenset) vil bli prioritert som følger: polysykliske aromatiske hydrokarboner (PAH) biomarkører, levoglucosan, biomarkører for flyktige organiske kjemikalier (VOC), tungmetaller og tobakksrelaterte biomarkører.
Urinbiomarkører vil bli målt hos gravide kvinner ved baseline, 24-28 ukers svangerskap og 32-36 ukers svangerskap, og hos nybakte mødre når barnet er 24 måneder gammelt.
Biomarkører vil bli målt hos eldre voksne kvinner ved baseline, 3, 6, 9, 12 og 18 måneder etter randomisering.
Biomarkører vil bli målt hos barn ved 3, 6, 12 og 24 måneders alder.
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Baseline, 3, 6, 9, 12 og 18 måneder etter randomisering og 24 måneders alder av barnet
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Endring i biomarkører for tørkede blodflekker (DBS).
Tidsramme: Baseline, 3, 6, 9, 12 og 18 måneder etter randomisering, og ved 24 måneders alder av barnet
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De viktigste biomarkørene som skal måles fra de tørkede blodflekkene er: betennelsesmarkører, endotelmarkører for kardiovaskulær sykdom, oksidative stressmarkører, Hb, HbA1C, tumorassosierte antigenantistoffer, cytokrom P450, p53 tumorassosiert antigen (TAA), lipider, metabolomics, MiRNA, tungmetaller.
DBS-biomarkører vil bli målt hos gravide kvinner ved baseline, 24-28 ukers svangerskap og 32-36 ukers svangerskap, og hos nybakte mødre når barnet er 24 måneder gammelt.
DBS-biomarkører vil bli målt hos eldre voksne kvinner ved baseline, 3, 6, 9, 12 og 18 måneder etter randomisering.
DBS-biomarkører vil bli målt hos barn ved 3, 6, 12 og 24 måneders alder.
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Baseline, 3, 6, 9, 12 og 18 måneder etter randomisering, og ved 24 måneders alder av barnet
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Maternal Perceived Stress Scale (PSS)
Tidsramme: 9 til 18 måneder etter randomisering (3 til 12 måneders alder av barnet)
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10-elementet Cohen's Perceived Stress Scale (PPS) vurderer måten en person vurderer sine livshendelser som stressende (f.eks. "I løpet av den siste måneden, hvor ofte har du følt at vanskeligheter hopet seg opp så høyt at du ikke kunne overvinne dem?" ) (Cohen, 1983).
Svarene på Likert-nivå varierte fra 0 (aldri) til 4 (veldig ofte), noe som betyr at en høy PPS-score vil resultere i et høyt nivå av opplevd stress.
En spanskspråklig PPS opprettet og testet og funnet å være gyldig og pålitelig (Vallijo et al., 2018).
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9 til 18 måneder etter randomisering (3 til 12 måneders alder av barnet)
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For tidlig fødsel
Tidsramme: Fødsel
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Inkludert prematur fødsel og dødfødsel.
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Fødsel
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Husholdningenes matusikkerhet
Tidsramme: Baseline, 18 måneder etter randomisering
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Husholdningers matusikkerhet vil bli målt ved hjelp av Food Insecurity Experience Scale (FIES), utviklet og validert av Food and Agriculture Organization (FAO).
FIES-modulen inneholder åtte spørsmål, hver med ja/nei svaralternativer, om husholdningens tilgang til tilstrekkelig mat, og er ment å måle tre domener av matusikkerhet: usikkerhet/angst, matmengde og matkvalitet.
Hvert spørsmål har verdier på 0/1, som summeres for en mulig totalscore på 0-8.
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Baseline, 18 måneder etter randomisering
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Kostholdsmangfold - kvinner
Tidsramme: Baseline til 18 måneder etter randomisering
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Kostholdsmangfold for kvinner vil bli målt ved å bruke spørreskjemaet Minimum Dietary Diversity - Women (MDD-W) fra FAO og FHI 360, som bruker et åpent tilbakekallingsformat for å samle inn data om mat og drikke som ble konsumert av respondenten i løpet av dagen og natten før. .
Svarene vil bli kategorisert i ti matvaregrupper, og kvinner som rapporterer at de spiser fem eller mer av ti matvaregrupper, vil bli kategorisert som å oppnå et minimum av kostholdsmangfold.
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Baseline til 18 måneder etter randomisering
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Hemoglobin (Hb) konsentrasjon / anemi - kvinner
Tidsramme: Baseline, 3 og 5 måneder etter randomisering
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Hb vil bli målt fra en enkelt dråpe med kapillærblod oppnådd via fingerstikk, ved hjelp av HemoCue® Hb 201system (HemoCue® AB) behandlingsenhet
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Baseline, 3 og 5 måneder etter randomisering
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Hemoglobin (Hb) konsentrasjon / anemi - spedbarn
Tidsramme: 12 og 18 måneder etter randomisering (6 og 12 måneder gammel)
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Hb vil bli målt fra en enkelt dråpe med kapillærblod oppnådd via fingerstikk, ved hjelp av HemoCue® Hb 201system (HemoCue® AB) behandlingsenhet
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12 og 18 måneder etter randomisering (6 og 12 måneder gammel)
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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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Thomas Clasen, PhD, Emory University
- Hovedetterforsker: Jennifer Peel, PhD, Colorado State University
- Hovedetterforsker: William Checkley, MD PhD, Johns Hopkins School of Medicine
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
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