Trial Summary
What is the purpose of this trial?This trial is testing if giving extra protein to very preterm infants helps with their growth and gut health. The goal is to see if protein supplementation leads to better growth and a more diverse gut microbiome.
Eligibility Criteria
This trial is for very preterm infants with a birth weight under 1800 grams and aged less than 96 hours, born between 29 to 33 weeks of gestation. It's not suitable for babies small for their gestational age, those with terminal illnesses where support is limited, or major congenital/chromosomal anomalies.Inclusion Criteria
My birth weight was under 1800 grams.
My baby is less than 4 days old.
I am between 29 and 33 weeks pregnant.
Exclusion Criteria
I have a significant birth defect or genetic disorder.
Small for gestational age (less than 5th percentile)
Terminal illness needing withhold or limit support
Participant Groups
The study tests if giving very preterm infants protein supplements early (between day 4-7) versus later (day 10-14) affects their body composition and gut bacteria diversity. The trial randomly assigns infants to one of the two groups.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early human milk fortification (HMF) groupExperimental Treatment1 Intervention
A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.
Group II: Delayed human milk fortification (HMF) groupActive Control1 Intervention
A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
Mead Johnson NutritionIndustry Sponsor