Status:
COMPLETED
Weight Patterns in the Month After Birth
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Makerere University
Aga Khan University
Conditions:
Stunting
Wasting
Eligibility:
All Genders
Up to 24 years
Brief Summary
This is a prospective cohort study that will be conducted in four low income countries to describe newborn weight patterns in the first month after birth and their association with clinical and demogr...
Detailed Description
Background: Worldwide, more than 50 million children under 5 are wasted (weight-for-length/height Z-score (WLZ) \<-2) and over 150 million children under 5 are stunted (length/height-for-age Z-score (...
Eligibility Criteria
Inclusion
- Birth weight ≥ 2000g.
- Mother ≥18 years of age and intends to breastfeed for at least 6 months.
- Mother anticipates availability for all study visits.
Exclusion
- Birth weight \<2000g
- Respiratory distress including tachypnea, head nodding, nasal flaring, chest retractions or grunting
- Known major congenital anomalies including orofacial clefts, neural tube defects and congenital heart defects
- Contraindication to breastfeeding at each site as determined by a site's national or sub-national health authorities
- Twins and other multiples.
- Newborns whose birth weight was not obtained in the first six hours.
- Newborns whose mothers intend to move or otherwise become unavailable during the follow up period of 30 days after birth
Key Trial Info
Start Date :
April 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2021
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT04025827
Start Date
April 22 2019
End Date
February 21 2021
Last Update
May 13 2021
Active Locations (5)
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1
University of California, San Francisco
San Francisco, California, United States, 94122
2
International Partnership for Human Development
Bissau, Guinea-Bissau
3
Dhulikhel Hospital
Dhulikhel, Nepal
4
Aga Khan University
Karachi, Pakistan