Status:
COMPLETED
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Centre for Infectious Disease Research in Zambia
Chiesi Foundation
Conditions:
Postnatal Growth Restriction
Eligibility:
All Genders
1-7 years
Phase:
NA
Brief Summary
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital disc...
Detailed Description
The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) usi...
Eligibility Criteria
Inclusion
- Between 28 0/7 to 31 6/7 weeks of age or weighing between 1000-1999 grams,
- Admitted to the UTH NICU within 24 hours after birth, and
- Infants who have reached feeding volume ≥120 mL/kg/day at time of randomization
Exclusion
- Who are deemed unstable by the neonatologist,
- With necrotizing enterocolitis or intestinal perforation
- Known gastrointestinal malformations,
- Major malformations or congenital anomalies, and
- Whose parents do not provide informed consent
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2023
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT05403684
Start Date
June 13 2022
End Date
February 10 2023
Last Update
February 14 2023
Active Locations (1)
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1
University Teaching Hospital
Lusaka, Zambia, 10101