Targeted Fortification of Donor Breast Milk in Preterm Infants (NCT04294368)
🩺 Plain-English Summary (8th-Grade Level)
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Who can join: Review the eligibility criteria below.
Location: Columbia University Medical Center/ New York - Presbyterian — New York, New York
Age range: 1 Day to 21 Days
🧪 Interventions in This Study
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (DIETARY_SUPPLEMENT)
- Similac Liquid Protein Fortifier (DIETARY_SUPPLEMENT)
- Nestle Microlipid (DIETARY_SUPPLEMENT)
- Medica Nutrition SolCarb (DIETARY_SUPPLEMENT)
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification) (DIETARY_SUPPLEMENT)
- Similac Liquid Protein Fortifier (Targeted Fortification) (DIETARY_SUPPLEMENT)
- Nestle Microlipid (Targeted Fortification) (DIETARY_SUPPLEMENT)
- Medica Nutrition SolCarb (Targeted Fortification) (DIETARY_SUPPLEMENT)
📋 "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)
- Columbia University Medical Center/ New York - Presbyterian — New York, New York
📞 Contact the Study Coordinator
Phone: (212) 305-0952
Email: mg71@cumc.columbia.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk — Birmingham, Alabama
- Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants — Montreal, Quebec
Explore by condition: All Prematurity; Extreme clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.