PT  - JOURNAL ARTICLE
AU  - Stella M Hartinger
AU  - Nestor Nuño
AU  - Jan Hattendorf
AU  - Hector Verastegui
AU  - Mariela Ortiz
AU  - Daniel Mäusezahl
TI  - A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings
AID  - 10.1101/465856
DP  - 2018 Jan 01
TA  - bioRxiv
PG  - 465856
4099  - http://biorxiv.org/content/early/2018/11/14/465856.short
4100  - http://biorxiv.org/content/early/2018/11/14/465856.full
AB  - Background Exposure to unhealthy environments and poor cognitive development are the main risk factors that affect children’s health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and an early child development programme to improve diarrhoea, acute respiratory infections and childhood developmental outcomes in children under 36 months of age living in resource-limited rural Andean Peru.Methods We collected baseline data on children’s developmental performance, health status and demography as well as microbial contamination in drinking water. In a sub-sample of households, we measured indoor and personal 24-hour air concentration levels of carbon monoxide (CO) and fine particulate matter (PM2.5).Results We recruited and randomised 317 children from 40 community-clusters to four study arms. At baseline, all arms had similar health and demographic characteristics, and the developmental status of children was comparable between arms. The analysis revealed that more than 25% of mothers completed primary education, a large proportion of children were stunted and diarrhoea prevalence was above 18%. Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms. The mean levels of kitchen PM2.5 and CO concentrations were 213 μg/m3 and 4.8 ppm, respectively.Conclusions The trial arms are balanced with respect to most baseline characteristics, such as household air and water pollution, and child development. These results ensure the possible estimation of the trial effectiveness. This trial will yield valuable information for assessing synergic, rational and cost-effective benefits of the combination of home-based interventions.Trial registration retrospectively registered on 15th January 2018. SRCTN reference: 26548981AAFAcompañamiento a FamiliasARIAcute respiratory infectionsBSIDBayley Scales of Infant and Toddler Development toolCBTCapacity building teamCOCarbon monoxideECDEarly child developmentESDIPeruvian infant development scale toolEVEnvironmental teamFWFieldworker teamHAPHousehold air pollutionICSImproved cookstovesIHIPIntegrated home-based intervention packageMINSAPeruvian Ministry of HealthMFMother facilitatorsPM2.5fine particulate matterPNCMProgram Nacional Cuna MasPPOPortable pulse oximetersPSPassive surveillance teamSENCICOPeruvian national industrial certification authoritySpO2Oxygen saturation in bloodTATechnical assistant teamWHOWorld Health Organization