Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk (NCT04325308)
Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial
🩺 Plain-English Summary (8th-Grade Level)
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 fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 1 Day to 4 Days
🧪 Interventions in This Study
- Protein-enriched human milk diet (PROCEDURE)
- Usual human milk diet (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prematurity; Extreme
- Assessment of Renal Function in Adults Born Preterm: The HAPI-Kidney Study — Montreal, Quebec
- Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm — Birmingham, Alabama
- Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants — Montreal, Quebec
- Targeted Fortification of Donor Breast Milk in Preterm Infants — New York, New York
Explore by condition: All Prematurity; Extreme clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.