Background: Exposure to unhealthy environments and inadequate child stimulation are 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 kitchen 24-h air concentration levels of carbon monoxide (CO) and fine particulate matter (PM 2.5 ) and CO for personal exposure. 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 PM 2.5 and CO concentrations were 213 μg/m 3 and 4.8 ppm, respectively. (Continued on next page)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 Registry: ISRCTN-26548981.

Background: The procedures needed to insert nasojejunal tubes (NJTs) are often invasive or uncomfortable for the patient and require hospital resources. The objectives of this study were to describe our experience in inserting a self-propelling NJT with distal pigtail end and evaluate clinical validity and cost efficacy of this enteral nutrition (EN) approach compared with parenteral nutrition (PN). Materials and Methods: Prospective study from July 2009 to December 2010, including hospitalized noncritical patients who required short-term jejunal EN. The tubes were inserted at bedside, using intravenous erythromycin as a prokinetic drug. Positioning was considered correct when the distal end was beyond the ligament of Treitz. Migration failure was considered when the tube was not positioned into the jejunum within 48 hours postinsertion. Results: Fifty-six insertions were recorded in 47 patients, most frequently in severe acute pancreatitis (69.6%). The migration rates at 18 and 48 hours postinsertion were 73.2% and 82.1%, respectively. There was migration failure in 8.9% of cases, and 8.9% were classified null (the tube was no longer in the gastrointestinal tract at 18 hours). There were no reported or observed complications. The mean duration of the EN was 12 ± 10.8 days. Five different types of EN formula were used. The total study cost was 53.9% lower compared with using PN in all patients. Conclusions: Our study demonstrated that bedside insertion of a self-propelling NJT is a safe, cost-effective, and successful technique for postpyloric enteral feeding in at least 73% of the patients, and only 18% of patients could eventually need other placement techniques. It can avoid the need for more aggressive or expensive placement techniques or even PN if we cannot achieve enteral access.

ABSTRACTBackgroundExposure 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.MethodsWe 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).ResultsWe 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.ConclusionsThe 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 registrationretrospectively registered on 15th January 2018. SRCTN reference: 26548981

Background Unsafe drinking water, poor sanitation and hygiene, exposure to household air pollution and low cognitive and socio-emotional stimulation are risk factors affecting children in low- and middle-income countries. We implemented an integrated home-environmental intervention package (IHIP), comprising a kitchen sink, hygiene education and a certified improved biomass cookstove, and an early child development (ECD) programme to improve children´s health and developmental outcomes in the rural high-altitude Andes of Peru. Methods We conducted a one-year cluster-randomised controlled trial among 317 children < 36 months divided into 4 arms (IHIP + ECD, IHIP, ECD, and Control) and 40 clusters (10 clusters per arm). ECD status (socio-emotional, fine and gross motor, communication, cognitive skills, and an overall performance) measured with the Peruvian Infant Development Scale and the occurrence of self-reported child diarrhoea from caretakers were primary outcomes. Secondary outcomes included the occurrence of acute respiratory infections and the presence of thermo-tolerant faecal bacteria in drinking water. The trial was powered to compare each intervention against its control arm but it did not allow pairwise comparisons among the four arms. Primary analysis followed the intention-to-treat principle. For the statistical analysis, we employed generalised estimating equation models with robust standard errors and an independent correlation structure. Results We obtained ECD information from 101 children who received the ECD intervention (individually and combined with IHIP) and 102 controls. Children who received the ECD intervention performed better in all the domains compared to controls. We found differences in the overall performance (64 vs. 39%, odd ratio (OR): 2.8; 95% confidence interval (CI): 1.6–4.9) and the cognitive domain (62 vs 46%, OR: 1.9; 95% CI: 1.1–3.5). Data analysis of child morbidity included 154 children who received the IHIP intervention (individually and combined with ECD) and 156 controls. We recorded 110,666 child-days of information on diarrhoea morbidity and observed 1.3 mean episodes per child-year in the children who received the IHIP intervention and 1.1 episodes in the controls. This corresponded to an incidence risk ratio of 1.2 (95% CI: 0.8–1.7). Conclusions Child stimulation improved developmental status in children, but there was no health benefit associated with the home-environmental intervention. Limited year-round access to running water at home and the possible contamination of drinking water after boiling were two potential factors linked to the lack of effect of the home-environmental intervention. Potential interactions between ECD and home-environmental interventions need to be further investigated. Trial registration: ISRCTN, ISRCTN-26548981. Registered 15 January 2018—Retrospectively registered, https://doi.org/10.1186/ISRCTN26548981. Graphical abstract