- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02944682
Huishoudelijke luchtverontreiniging en gezondheid: een LPG-interventieproef in meerdere landen (HAPIN)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Wereldwijd zijn bijna 3 miljard mensen afhankelijk van vaste brandstoffen voor koken en verwarmen, de overgrote meerderheid in lage- en middeninkomenslanden (LMIC's). De resulterende luchtvervuiling door huishoudens (HAP) is de derde belangrijkste risicofactor in de wereldwijde ziektelast van 2010, goed voor naar schatting 4,3 miljoen sterfgevallen per jaar, voornamelijk onder vrouwen en jonge kinderen. Eerdere interventies hebben gezorgd voor schonere fornuizen op basis van biomassa, maar zijn er niet in geslaagd de blootstelling te verminderen tot niveaus die een zinvolle gezondheidsverbetering opleveren. Er zijn geen grootschalige veldproeven gedaan met fornuizen op vloeibaar petroleumgas (LPG), waarschijnlijk de schoonste schaalbare interventie.
Het doel van deze studie is om een gerandomiseerde gecontroleerde proef uit te voeren van LPG-kachel en brandstofdistributie in 3.200 huishoudens in vier LMIC's (India, Guatemala, Peru en Rwanda) om rigoureus bewijs te leveren met betrekking tot mogelijke gezondheidsvoordelen gedurende de hele levensduur. Elke interventiesite zal 800 zwangere vrouwen rekruteren (leeftijd 18-34 jaar, 9 - <20 weken zwangerschap), en zal willekeurig de helft van hun huishoudens toewijzen om LPG-fornuizen en een voorraad LPG voor 18 maanden te ontvangen. Van controlehuishoudens wordt verwacht dat ze voornamelijk blijven koken met vaste biomassabrandstoffen en een vergoeding zullen ontvangen op basis van een uniforme reeks proefbrede principes, aangepast aan elke locatie op basis van vormend onderzoek. De moeder wordt samen met haar kind gevolgd tot het kind 1 jaar oud is. In huishoudens met een tweede, niet-zwangere oudere volwassen vrouw (in de leeftijd van 40 tot <80 jaar) zullen de onderzoekers haar ook inschrijven en volgen tijdens de follow-upperiode van 18 maanden om cardiopulmonale, metabole en kankerresultaten te beoordelen. Om het interventiegebruik te optimaliseren, zullen de onderzoekers strategieën voor gedragsverandering implementeren. Deze studie beoordeelt het gebruik van kookfornuizen, voert herhaalde persoonlijke blootstellingsbeoordelingen uit aan HAP (PM2.5, zwarte koolstof, koolmonoxide) en verzamelt gedroogde bloedvlekken en urinemonsters voor biomarkeranalyse en opslag van biospecimen op alle deelnemers op meerdere tijdstippen. De primaire uitkomsten zijn laag geboortegewicht, ernstige incidentie van longontsteking en groeiachterstand van het kind, en bloeddruk bij de oudere volwassen vrouw. Secundaire uitkomsten zijn vroeggeboorte en ontwikkeling bij het kind, maternale bloeddruk tijdens de zwangerschap en endotheelfunctie, ademhalingsstoornissen, atherosclerose, carcinogene metabolieten en kwaliteit van leven bij de oudere volwassen vrouw.
Deze studie richt zich op de volgende specifieke doelen: (1) met behulp van een intent-to-treat-analyse het effect bepalen van een gerandomiseerde LPG-kachel en brandstofinterventie op de gezondheid in vier verschillende LMIC-populaties met behulp van een gemeenschappelijk protocol; (2) de blootstelling-responsrelaties voor HAP en gezondheidsuitkomsten bepalen; en (3) relaties bepalen tussen LPG-interventie en zowel gerichte als verkennende biomarkers van blootstelling/gezondheidseffecten.
Deze studie zal bewijs leveren, inclusief kosten en implementatiestrategieën, om nationaal en mondiaal beleid te informeren over het opschalen van LPG-fornuizen onder kwetsbare bevolkingsgroepen. Uiteindelijk zal dit diepere discussies op beleidsniveau vergemakkelijken en de vereisten identificeren voor het wereldwijd initiëren en ondersteunen van HAP-interventies.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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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, Indië, 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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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria voor zwangere vrouwen:
- Bevestigde zwangerschap (hCG-positieve bloed- of urinetest)
- Van 18 tot <35 jaar (via zelfrapportage)
- Gebruikt voornamelijk biomassakachel
- Woont in studiegebied
- 9 - <20 weken zwangerschap bevestigd door echografie
- Eenlingzwangerschap (één foetus)
- Levensvatbare foetus met normale foetale hartslag (120-180 slagen per minuut) op het moment van echografie
- Doorgaande zwangerschap op het moment van randomisatie bevestigd door zelfrapportage
- Stemt ermee in om deel te nemen met geïnformeerde toestemming
Uitsluitingscriteria voor zwangere vrouwen:
- Rookt momenteel sigaretten of andere tabaksproducten
- Plannen om in de komende 12 maanden definitief buiten het studiegebied te verhuizen
- Gebruikt overwegend LPG-kachel of zal in de nabije toekomst waarschijnlijk overwegend LPG gebruiken
Inclusiecriteria voor oudere volwassen vrouw in hetzelfde huishouden:
- Leeftijd 40 tot <80 jaar (via zelfrapportage)
Uitsluitingscriteria voor oudere volwassen vrouw in hetzelfde huishouden:
- Rookt momenteel sigaretten of andere tabaksproducten
- Zwanger (door zelfrapportage)
- Plannen om in de komende 12 maanden uit haar huidige huishouden te verhuizen
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Kooktoestel op vloeibaar petroleumgas
Deelnemers gerandomiseerd naar de experimentele arm ontvangen een kookfornuis op vloeibaar petroleumgas (LPG) en LPG voor 18 maanden.
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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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Geen tussenkomst: Controle
Deelnemers aan de controlegroep krijgen geen kooktoestel op vloeibaar petroleumgas (LPG) en blijven traditionele kookmethodes gebruiken (open vuur of traditionele kachels), of de kookmethode van hun keuze.
Controlehuishoudens zullen een vergoeding ontvangen op basis van een uniforme reeks proefbrede principes, aangepast aan elke locatie op basis van formatief onderzoek.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Birth weight
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Vroeggeboorte
Tijdsspanne: Tot 5 maanden (binnen 24 uur na de geboorte, 3-5 maanden na randomisatie)
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Vroeggeboorte wordt gedefinieerd als de bevalling van een levend kind vóór 37 voltooide weken zwangerschap.
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Tot 5 maanden (binnen 24 uur na de geboorte, 3-5 maanden na randomisatie)
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Ziekenhuisopname voor luchtwegaandoeningen
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van ziekenhuisopnames voor een luchtwegaandoening tijdens het eerste levensjaar.
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Tot 12 maanden na de geboorte
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WHO Niet-ernstige longontsteking
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van niet-ernstige pneumonie van de WHO (definitie van 2014 en definitie van 2013) tijdens het eerste levensjaar.
Gevallen van longontsteking worden geregistreerd wanneer kinderen zich met ademhalingssymptomen bij HAPIN gezondheidscentra melden.
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Tot 12 maanden na de geboorte
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WHO Ernstige longontsteking
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van niet-ernstige pneumonie van de WHO (definitie van 2014 en definitie van 2013) tijdens het eerste levensjaar.
Gevallen van longontsteking worden geregistreerd wanneer kinderen zich met ademhalingssymptomen bij HAPIN gezondheidscentra melden.
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Tot 12 maanden na de geboorte
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WHO Pocket Book Niet-ernstige longontsteking
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van WHO niet-ernstige pneumonie tijdens het eerste levensjaar, zoals gedefinieerd in de tweede editie van het "Pocket book of hospital care for children" (2013).
Gevallen van longontsteking worden geregistreerd wanneer kinderen zich met ademhalingssymptomen bij HAPIN gezondheidscentra melden.
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Tot 12 maanden na de geboorte
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WHO Pocket Book ernstige longontsteking
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van ernstige longontsteking bij de WHO tijdens het eerste levensjaar, zoals gedefinieerd in de tweede editie van het "Pocket book of hospital care for children" (2013).
Gevallen van longontsteking worden geregistreerd wanneer kinderen zich met ademhalingssymptomen bij HAPIN gezondheidscentra melden.
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Tot 12 maanden na de geboorte
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Hypoxemische longontsteking
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van hypoxemische pneumonie tijdens het eerste levensjaar.
Gevallen van longontsteking worden geregistreerd wanneer kinderen zich met ademhalingssymptomen bij HAPIN gezondheidscentra melden.
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Tot 12 maanden na de geboorte
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Echografie of röntgenfoto longontsteking
Tijdsspanne: Tot 12 maanden na de geboorte
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Cumulatieve incidentie van pneumonie van de longen of thoraxfoto's gedurende het eerste levensjaar.
Gevallen van longontsteking worden geregistreerd wanneer kinderen zich met ademhalingssymptomen bij HAPIN gezondheidscentra melden.
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Tot 12 maanden na de geboorte
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Gestational Systolic Blood Pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Spontane abortie
Tijdsspanne: Basislijn tot 20 weken zwangerschap
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Foetale dood vóór 19 weken 6 dagen.
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Basislijn tot 20 weken zwangerschap
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Vroeggeboorte
Tijdsspanne: Geboorte
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Geboorten met een zwangerschapsduur van minder dan 34 weken, onder alle levendgeborenen.
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Geboorte
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Doodgeboorte
Tijdsspanne: Tot aan de geboorte
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Elke foetale dood die optreedt bij of na een zwangerschap van 20 weken OF aangegeven op het formulier Ernstige ongewenste voorvallen OF op het formulier Medische geschiedenis zwangere vrouw OF op het formulier mondelinge autopsie.
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Tot aan de geboorte
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Neonatale dood
Tijdsspanne: Geboorte tot en met 28 dagen
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Overlijden tussen geboorte en 28 dagen.
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Geboorte tot en met 28 dagen
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Longfunctie van het kind
Tijdsspanne: 36, 48 en 60 maanden oud
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Longfunctiemetingen zullen worden uitgevoerd met behulp van de geforceerde oscillatietechniek (FOT) met het Tremoflo C-100-apparaat met wegwerpmondstukken.
FOT is een techniek die vroege veranderingen in de luchtwegen kan identificeren.
Het FOT-apparaat meet de relatie tussen extern uitgeoefende drukgolven en de resulterende luchtstroom om de ademhalingsimpedantie te meten.
Waarden geproduceerd bij hoge frequenties komen overeen met de proximale en grote luchtwegen, en waarden geproduceerd bij lage frequenties komen overeen met distale en kleine luchtwegen.
Deze meting zal worden uitgevoerd bij kinderen in Guatemala.
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36, 48 en 60 maanden oud
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Verandering in urinebiomarkers
Tijdsspanne: Basislijn, 3, 6, 9, 12 en 18 maanden na randomisatie, en 24 maanden oud van het kind
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Biomarkers voor meervoudige blootstelling zullen worden gemeten: 3-OH Cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), levoglucosan, 8OH-deoxyguanosine (8OHdG) en metabolieten van vluchtige organische chemicaliën (VOC). .
Blootstellingsbiomarkers (vooral voor kinderen van wie de urine mogelijk beperkt is) zullen als volgt prioriteit krijgen: biomarkers van polycyclische aromatische koolwaterstoffen (PAK), levoglucosan, biomarkers van vluchtige organische chemicaliën (VOC), zware metalen en tabaksgerelateerde biomarkers.
Urine-biomarkers zullen worden gemeten bij zwangere vrouwen bij aanvang, 24-28 weken zwangerschap en 32-36 weken zwangerschap, en bij nieuwe moeders wanneer het kind 24 maanden oud is.
Biomarkers zullen worden gemeten bij oudere volwassen vrouwen bij aanvang, 3, 6, 9, 12 en 18 maanden na randomisatie.
Biomarkers zullen worden gemeten bij kinderen van 3, 6, 12 en 24 maanden oud.
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Basislijn, 3, 6, 9, 12 en 18 maanden na randomisatie, en 24 maanden oud van het kind
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Verandering in biomarkers voor gedroogde bloedvlekken (DBS).
Tijdsspanne: Basislijn, 3, 6, 9, 12 en 18 maanden na randomisatie, en op de leeftijd van 24 maanden van het kind
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De belangrijkste biomarkers die uit de gedroogde bloedvlekken moeten worden gemeten zijn: ontstekingsmarkers, endotheliale markers van hart- en vaatziekten, oxidatieve stressmarkers, Hb, HbA1C, tumor-geassocieerde antigeenantilichamen, cytochroom P450, p53 tumor-geassocieerd antigeen (TAA), lipiden, metabolomics, MiRNA, zware metalen.
DBS-biomarkers zullen worden gemeten bij zwangere vrouwen bij aanvang, 24-28 weken zwangerschap en 32-36 weken zwangerschap, en bij nieuwe moeders wanneer het kind 24 maanden oud is.
DBS-biomarkers zullen worden gemeten bij oudere volwassen vrouwen bij aanvang, 3, 6, 9, 12 en 18 maanden na randomisatie.
DBS-biomarkers zullen worden gemeten bij kinderen van 3, 6, 12 en 24 maanden oud.
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Basislijn, 3, 6, 9, 12 en 18 maanden na randomisatie, en op de leeftijd van 24 maanden van het kind
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Maternale waargenomen stressschaal (PSS)
Tijdsspanne: 9 tot 18 maanden na randomisatie (3 tot 12 maanden oud van het kind)
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De uit 10 items bestaande Cohen's Perceived Stress Scale (PPS) beoordeelt de manier waarop iemand zijn of haar levensgebeurtenissen als stressvol beoordeelt (bijvoorbeeld: 'Hoe vaak heeft u de afgelopen maand het gevoel gehad dat de moeilijkheden zich zo hoog opstapelden dat u ze niet kon overwinnen?' ) (Cohen, 1983).
De antwoorden op Likert-niveau varieerden van 0 (nooit) tot 4 (heel vaak), wat betekent dat een hoge PPS-score zou resulteren in een hoog niveau van waargenomen stress.
Een Spaanstalige PPS gemaakt en getest en valide en betrouwbaar bevonden (Vallijo et al., 2018).
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9 tot 18 maanden na randomisatie (3 tot 12 maanden oud van het kind)
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Vroegtijdige bevalling
Tijdsspanne: Geboorte
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Inclusief vroeggeboorte en doodgeboorte.
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Geboorte
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Voedselonzekerheid van huishoudens
Tijdsspanne: Basislijn, 18 maanden na randomisatie
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De voedselonzekerheid van huishoudens zal worden gemeten met behulp van de Food Insecurity Experience Scale (FIES), ontwikkeld en gevalideerd door de Voedsel- en Landbouworganisatie (FAO).
De FIES-module bevat acht vragen, elk met ja/nee-antwoordmogelijkheden, over de toegang van het huishouden tot voldoende voedsel, en is bedoeld om drie domeinen van voedselonzekerheid te meten: onzekerheid/angst, voedselkwantiteit en voedselkwaliteit.
Elke vraag heeft waarden van 0/1, die worden opgeteld voor een mogelijke totaalscore van 0-8.
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Basislijn, 18 maanden na randomisatie
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Dieetdiversiteit - vrouwen
Tijdsspanne: Basislijn tot 18 maanden na randomisatie
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De voedingsdiversiteit voor vrouwen zal worden gemeten met behulp van de Minimum Dietary Diversity - Women (MDD-W) vragenlijst van de FAO en FHI 360, die een open recall-format gebruikt om gegevens te verzamelen over voedsel en dranken die de respondent de afgelopen dag en nacht heeft geconsumeerd. .
De antwoorden zullen worden onderverdeeld in tien voedselgroepen en vrouwen die aangeven vijf of meer van de tien voedselgroepen te consumeren, zullen worden gecategoriseerd als mensen die een minimale voedingsdiversiteit bereiken.
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Basislijn tot 18 maanden na randomisatie
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Hemoglobine (Hb) concentratie / bloedarmoede - vrouwen
Tijdsspanne: Basislijn, 3 en 5 maanden na randomisatie
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Het Hb wordt gemeten uit een enkele druppel capillair bloed verkregen via een vingerprik, met behulp van het HemoCue® Hb 201system (HemoCue® AB) point-of-care-apparaat
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Basislijn, 3 en 5 maanden na randomisatie
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Hemoglobine (Hb)-concentratie / bloedarmoede - zuigelingen
Tijdsspanne: 12 en 18 maanden na randomisatie (6 en 12 maanden oud)
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Het Hb wordt gemeten uit een enkele druppel capillair bloed verkregen via een vingerprik, met behulp van het HemoCue® Hb 201system (HemoCue® AB) point-of-care-apparaat
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12 en 18 maanden na randomisatie (6 en 12 maanden oud)
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Change in fine particulate matter (PM2.5) exposure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Thomas Clasen, PhD, Emory University
- Hoofdonderzoeker: Jennifer Peel, PhD, Colorado State University
- Hoofdonderzoeker: William Checkley, MD PhD, Johns Hopkins School of Medicine
Publicaties en nuttige links
Algemene publicaties
- 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.
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- 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.
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- 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.
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