NCT04294368 Targeted Fortification of Donor Breast Milk in Preterm Infants
| NCT ID | NCT04294368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Prematurity; Extreme |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-03-09 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-03-09 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Premature infants born \</= 30 weeks gestational age * Birth Weight \</= 1500 grams Exclusion Criteria: * Parents do no consent to donor milk * Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies * Grade III or IV intraventricular hemorrhage diagnoses prior to randomization * Small for gestational age (\<3% on Fenton Growth Curve) * Failure to initiate fortified feeds prior to 3 weeks of life * Diagnosis of necrotizing entercolitis prior to randomization * Diagnosis of early onset sepsis confirmed with positive culture
Contact & Investigator
Marianne Garland, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT04294368 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 21 Days, studying Prematurity; Extreme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04294368 currently recruiting?
Yes, NCT04294368 is actively recruiting participants. Contact the research team at mg71@cumc.columbia.edu for enrollment information.
Where is the NCT04294368 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04294368 clinical trial?
NCT04294368 is sponsored by Columbia University. The principal investigator is Marianne Garland, MD at Columbia University. The trial plans to enroll 50 participants.