CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,280 enrolled
Drug / intervention
Standard care +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01824940
NCT01824940N/ACompleted

Sanitation, Hygiene, Infant Nutrition Efficacy Project

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Apr 5, 2013·Updated Jul 26, 2018

In Brief

A clinical study evaluating Standard care, WASH, and 2 other interventions for Growth; Stunting, Nutritional and Anemia. Completed, enrolled 5,280 participants across 1 site.

Detailed Summary

Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of their mortality and leads to long-term cognitive deficits, fewer years and poorer performance in school, lower adult economic productivity, and a higher risk that their own children will also be stunted, perpetuating the problem into future generations. Stunting begins antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age Z-score (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of young children can reduce stunting, though, at best, only by about one-third. Frequent diarrheal illness has also been implicated. However, the effect of diarrhea on permanent stunting is relatively small, maybe because children grow at "catch-up" rates between illness episodes. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part premise: * A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED). EED is a subclinical disorder of the small intestine, which is virtually ubiquitous among asymptomatic people living in low-income settings throughout the world. EED is characterized by increased permeability which facilitates microbial translocation into the systemic circulation and triggers chronic immune activation. * The primary cause of EED is infant ingestion of fecal microbes due to living in conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 5, 2013
Enrollment StartNov 1, 2012
Primary CompletionJul 1, 2017
Study CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.2 years ago

Interventions

Standard carebehavioral

Standard Care: * Exclusive breastfeeding promotion for all infants, birth to 6 months * Strengthened PMTCT (prevention of mother to child transmission of HIV) services * Strengthened Village Health Worker system

WASHother

WASH: * Standard care interventions * Provide household ventilated pit latrine, water treatment solution, and monthly liquid soap, two hand-washing facilities and protected infant play space * Provide interpersonal communication interventions promoting feces disposal in a latrine, HWWS (hand washing with soap), drinking water treatment, hygienic weaning food preparation, and preventing babies from putting dirt and animal feces in their mouths.

Infant and young child feedingdietary

IYCF: * Standard care interventions * Provide 20 g/d Nutributter from 6-18 months * Provide interpersonal communication interventions promoting optimal use of locally available foods for complementary feeding after 6 months, continued breastfeeding and feeding during illness.

WASH and Nutritionother

WASH AND IYCF interventions * Standard care interventions * All WASH interventions * All IYCF interventions