Status:
ACTIVE_NOT_RECRUITING
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Prematurity; Extreme
Feeding Disorder Neonatal
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase ...
Detailed Description
Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control gro...
Eligibility Criteria
Inclusion
- Gestational age ≤ 28 weeks of gestation
- Postnatal age \< 96 hours
Exclusion
- Congenital malformations
- Chromosomal anomalies
- Terminal illness needing to limit or withhold support
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04325308
Start Date
August 13 2020
End Date
September 30 2026
Last Update
September 23 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233