Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01824940
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2012-03-27
Brief Title:
SHINE Sanitation Hygiene Infant Nutrition Efficacy Project
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Sanitation Hygiene Infant Nutrition Efficacy Project
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE
Brief 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 -20 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
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
Detailed Description:
The Sanitation Hygiene Infant Nutrition Efficacy SHINE trial will test the effects of two packages of interventions 1 improved water sanitation and hygiene WASH and 2 improved infant and young child feeding IYCF on child stunting and anemia in the first 18 months of life The trial will be conducted in rural Zimbabwe where WASH is poor food insecurity high and where about 15 of pregnant women are infected with HIV The study will enroll 5282 women early in pregnancy and follow them and their infants until 18 months after delivery The study will be a cluster-randomized controlled trial two entire districts in central Zimbabwe have been divided into 212 geographic areas each of about 100 households The areas will be randomly allocated that is assigned by according to chance like the flip of a coin to one of four interventions
1 Improved WASH a ventilated pit latrine hand washing facilities with soap drinking water treatment a protected play space and health lessons to adopt improved hygiene behaviors
2 Improved Infant Nutrition health lessons on best infant feeding practices and a nutritional supplement Nutributter to be fed daily to babies from 6 to 18 months
3 Improved WASH and Infant Nutrition both interventions
4 Standard of Care
All women living in the two districts who become pregnant during the recruitment period of the study will be invited to enroll They will receive one of the 4 packages of interventions according to the area where they live Health lessons will be given by Village Health Workers Latrines and hand washing facilities will be constructed by building teams Mothers will be followed up by research nurses at 7 months gestation and at 1 3 6 12 and 18 months after delivery Primary outcomes are infant height and hemoglobin at 18 months of age
Within SHINE we will measure two causal pathways the biomedical pathway and the program impact pathway
The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age it will be elucidated by measuring biomarkers of intestinal structure and function inflammation regeneration absorption and permeability microbial translocation systemic inflammation and hormonal determinants of growth and anemia among a subgroup of infants enrolled in an EED substudy The investigators will also ask these mothers to record daily any episodes of diarrhea bloodmucus in the stool cough fast or difficult breathing fever and lethargy preventing breastfeeding that the child has between 1 month and 18 months of age A subgroup of infants will also have stool samples collected during diarrhoeal episodes to evaluate reductions in pathogen-specific diarrhoea following WASH interventions
Since the mothers enrolled in SHINE will have lived in unsanitary living conditions throughout their lives it is anticipated that most will have some degree of EED themselves It is hypothesized that resulting chronic inflammation contributes to adverse birth outcomes such as prematurity and low birth weight This question will be investigated through an observational design For all mothers enrolled in SHINE the sugar absorption test described above will be conducted and specimens of saliva stool and blood collected and archived at the 10-12 week gestation visit for subsequent assessment of EED biomarkers The association of severity of EED with risk of adverse birth outcomes low birth length and weight miscarriage stillbirth and premature delivery will be assessed
The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the two child health outcomes it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices We will also measure a range of household and individual characteristics social interactions and maternal capabilities for childcare which we hypothesize will explain heterogeneity along these pathways
1 Improved WASH a ventilated pit latrine hand washing facilities with soap drinking water treatment a protected play space and health lessons to adopt improved hygiene behaviors
2 Improved Infant Nutrition health lessons on best infant feeding practices and a nutritional supplement Nutributter to be fed daily to babies from 6 to 18 months
3 Improved WASH and Infant Nutrition both interventions
4 Standard of Care
All women living in the two districts who become pregnant during the recruitment period of the study will be invited to enroll They will receive one of the 4 packages of interventions according to the area where they live Health lessons will be given by Village Health Workers Latrines and hand washing facilities will be constructed by building teams Mothers will be followed up by research nurses at 7 months gestation and at 1 3 6 12 and 18 months after delivery Primary outcomes are infant height and hemoglobin at 18 months of age
Within SHINE we will measure two causal pathways the biomedical pathway and the program impact pathway
The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age it will be elucidated by measuring biomarkers of intestinal structure and function inflammation regeneration absorption and permeability microbial translocation systemic inflammation and hormonal determinants of growth and anemia among a subgroup of infants enrolled in an EED substudy The investigators will also ask these mothers to record daily any episodes of diarrhea bloodmucus in the stool cough fast or difficult breathing fever and lethargy preventing breastfeeding that the child has between 1 month and 18 months of age A subgroup of infants will also have stool samples collected during diarrhoeal episodes to evaluate reductions in pathogen-specific diarrhoea following WASH interventions
Since the mothers enrolled in SHINE will have lived in unsanitary living conditions throughout their lives it is anticipated that most will have some degree of EED themselves It is hypothesized that resulting chronic inflammation contributes to adverse birth outcomes such as prematurity and low birth weight This question will be investigated through an observational design For all mothers enrolled in SHINE the sugar absorption test described above will be conducted and specimens of saliva stool and blood collected and archived at the 10-12 week gestation visit for subsequent assessment of EED biomarkers The association of severity of EED with risk of adverse birth outcomes low birth length and weight miscarriage stillbirth and premature delivery will be assessed
The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the two child health outcomes it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices We will also measure a range of household and individual characteristics social interactions and maternal capabilities for childcare which we hypothesize will explain heterogeneity along these pathways
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD060338 | NIH | None | httpsreporternihgovquickSearchR01HD060338 |