Status:
COMPLETED
Preventing Infant Malnutrition With Early Supplementation
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
International Partnership for Human Development
Makerere University
Conditions:
Underweight
Wasting
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
Background: Worldwide, more than 50 million children under 5 years of age are wasted (weight-for-length/height Z-score (WLZ) \<-2) and over 150 million children under 5 are stunted (length/height-for-...
Eligibility Criteria
Inclusion
- Infant \< 6 hours old
- Infant birth weight 2000-2885g
- Mother intends to breastfeed
- Mother with negative HIV test
- Mother lives in study catchment area and anticipates availability for all study visits
- Mother ≥18 years old
Exclusion
- Twins and other multiples
- Infant with known major congenital anomalies including orofacial clefts, neural tube defects or congenital heart defects
- Infant with WHO newborn and respiratory danger signs present:
- Not feeding well
- Convulsions
- Very fast breathing ≥60 breaths/minute
- Severe chest indrawing
- No spontaneous movement
- Lethargic or unconscious
- Raised temperature \> 37.5 degrees Celsius
- Hypothermia \<35.5 degrees Celsius
- Any jaundice in first 24 hours of life or yellow palms or soles at any age
- Head nodding, nasal flaring or grunting
- Maternal psychiatric or psychosocial barrier to enrollment:
- Contraindication to breastfeeding at each site as determined by a site's national or sub-national health authorities
- Mothers unable or unwilling to complete all aspects of the protocol Infant enrolled in another study
- Mother has had another infant enrolled in PRIMES
Key Trial Info
Start Date :
February 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT04704076
Start Date
February 28 2021
End Date
January 31 2023
Last Update
February 8 2023
Active Locations (2)
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1
International Partnership for Human Development
Bissau, Guinea-Bissau
2
Makerere University
Kampala, Uganda