An observational study in Diarrhea, Malnutrition and Stunting, sponsored by Foundation for the National Institutes of Health. Status unknown at 8 sites in 8 countries. Open to participants aged 1 Minute to 17 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by Foundation for the National Institutes of Health · Observational
Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality in children under five. An estimated 20% of children in the developing world are malnourished [1] and poor nutrition is linked to more than half of all child deaths worldwide [2]. Malnutrition in early childhood may lead to cognitive and physical deficits and may cause similar deficits in future generations as malnourished mothers give birth to low birth weight children [3]. In addition, malnutrition increases susceptibility and incidence of infections and is associated with diminished response to vaccines.
The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that alter gut function and impair children's nutrition, growth and development to help develop new intervention strategies that can break the vicious enteric infection-malnutrition cycle and reduce its global burden.
The overall objective of the MAL-ED Project is to quantify the associations of specific enteric pathogens, measures of physical and mental development, micronutrient malnutrition, gut function biomarkers, the gut microbiome, and immune responses in very young children in resource-limited settings across eight sites that vary by culture, economics, geography, and climate.
The central hypothesis of the MAL-ED Project is that infection (and co-infection) with specific enteropathogens leads to impaired growth and development and to diminished immune response to orally administered vaccines by causing intestinal inflammation and/or by altering intestinal barrier and absorptive function. Data analyses will test for associations between enteropathogen infections and growth/development to help illuminate:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1,796 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Foundation for the National Institutes of Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population for the MAL-ED Project is a birth cohort. Pregnant women were identified from their communities, consented and the child will be enrolled.
Exclusion Criteria:
Birth cohort study community in Bangladesh is urban, and located in the Mirpur neighborhood of Dhaka. Case control study is being conducted in the same catchment area. Cases defined as children 6-24 months of age with \<-2WAZ (weight for age) score, controls are age and community matched with \>-1WAZ.
Birth cohort study community in Brazil is urban, and located within the Papoco area of Fortaleza. Case control study is being conducted in the same area as the cohort study. Cases are children 6 - 24 months of age, with \<-2 WAZ (weight for age) score, controls are age and community matched children with \>-1 WAZ.
Birth cohort study community in India is urban, and located in the southern state of Tamil Nadu, specifically in Vellore.
Birth cohort study community in Nepal is semi-urban, and located in Bhaktapur, approximately 25km from Kathmandu.
Birth cohort study community in Pakistan is rural, and located in Naushero Feroze, Sindh.
Birth cohort study community in Peru is rural, and located approximately 15km from Iquitos in Loreto.
Birth cohort study community in South Africa is rural/peri-urban, and comprised of nine settlements within Limpopo Province.
Birth cohort study community in Tanzania is rural, and located within Haydom.
Diarrhea
All diarrheal samples are analyzed for the presence of bacterial, viral, and parasitic pathogens. Normal stool is collected monthly and analyzed for the same list of 57 different pathogens.
Time frame: Each diarrheal episode willbe recorded for up to 24 months of age.
Anthropometry
Head Circumference, length, and weight are measured monthly on the anniversary of the child's birth.
Time frame: Anthropomentry will be recorded each month for up to 24 months of age.
Cognitive development
A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices.
Time frame: Cognitive development will be recorded at 6 months of age.
Vaccine response
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Time frame: Vaccine response will be recorded at 7 months of age.
Cognitive development
A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices.
Time frame: Cognitive development will be recorded at 8 months of age.
Cognitive development
A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices.
Time frame: Cognitive development will be recorded at 15 months of age.
Vaccine response
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Time frame: Vaccine response will be recorded at 15 months of age.
Cognitive development
A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices.
Time frame: Cognitive development will be recorded 24 months of age.
Vaccine response
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Time frame: Vaccine response will be recorded at 24 months of age.
Gut inflammation
Stool biomarkers will be evaluated to detect gut and systemic inflammation.
Time frame: Gut inflammation will be recorded each month for up to 24 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Time frame: Gut integritywill be recorded at at 3 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Time frame: Gut integritywill be recorded at at 6 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Time frame: Gut integritywill be recorded at at 9 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Time frame: Gut integritywill be recorded at at 15 months of age.
This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Foundation for the National Institutes of Health