RecruitingNot Applicable

Targeted Fortification of Donor Breast Milk in Preterm Infants

United States50 participantsStarted 2020-03-09

Plain-language 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.

Who can participate

Age range1 Day – 21 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in weight

Timeframe: Up to 11 weeks

Change in length

Timeframe: Up to 11 weeks

Head circumference

Timeframe: Up to 11 weeks

Trial details

NCT IDNCT04294368

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Marianne Garland, MD

212 305 0952 mg71@cumc.columbia.edu

View on ClinicalTrials.gov More Prematurity; Extreme trials