RecruitingNot ApplicableNCT04294368

Targeted Fortification of Donor Breast Milk in Preterm Infants

Sponsor

Columbia University

Enrollment

50 participants

Start Date

Mar 9, 2020

Study Type

INTERVENTIONAL

Conditions

growth failure Prematurity; Extreme Failure to Thrive in Newborn Growth Retardation Infant Nutrition Disorders

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

Min Age: 1 DayMax Age: 21 Days

Plain Language Summary

Simplified for easier understanding

This study is comparing targeted fortification (adjusting nutrients based on regular breast milk testing) versus standard fortification of donor breast milk for premature babies in the NICU. Very premature babies need extra nutrients added to breast milk, but the composition of donor milk varies, and a one-size-fits-all approach may not meet each baby's specific needs. Targeted fortification aims to optimize nutrition for better growth outcomes. You may be eligible if: - Your baby was born at or before 30 weeks gestational age - Your baby weighed 1500 grams or less at birth You may NOT be eligible if: - Parents have not consented to the use of donor milk - Your baby has conditions that may significantly affect growth, such as congenital heart disease, gastroschisis, omphalocele, or other major birth defects - Your baby has a Grade III or IV intraventricular hemorrhage (brain bleed) diagnosed before randomization - Your baby is small for gestational age (below 3rd percentile on the Fenton Growth Curve) - Fortified feeds were not started within the first 3 weeks of life - Your baby has been diagnosed with necrotizing enterocolitis (NEC) before randomization - Your baby has a confirmed bloodstream infection (early onset sepsis with positive culture) Talk to your NICU care team about this study if your premature baby is receiving donor breast milk and you are interested in research on optimizing early nutrition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTSimilac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid

The control group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF.

DIETARY_SUPPLEMENTSimilac Liquid Protein Fortifier

For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.

DIETARY_SUPPLEMENTNestle Microlipid

DIETARY_SUPPLEMENTMedica Nutrition SolCarb

For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU.

DIETARY_SUPPLEMENTSimilac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)

The experimental group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF. For participants in the experimental group, the investigators will continue to add fortification. Two packets of HMF per day will be added until goal fortification is reached.

DIETARY_SUPPLEMENTSimilac Liquid Protein Fortifier (Targeted Fortification)

Participants in the experimental group will receive a dose that will vary depending on the base protein content in the donor breast milk for each particular batch of donor breast milk.

DIETARY_SUPPLEMENTNestle Microlipid (Targeted Fortification)

Participants in the experimental group will receive a dose that will vary depending on the base fat content in the donor breast milk for each particular batch of donor breast milk

DIETARY_SUPPLEMENTMedica Nutrition SolCarb (Targeted Fortification)

Participants in the experimental group will receive a dose that will vary depending on the base carbohydrate content in the donor breast milk for each particular batch of donor breast milk

OTHERAnalysis with Miris (AB) Human Milk Analyzer

For participants in both the control and the experimental arms, each batch of donor milk will be analyzed using the Miris Human Milk Analyzer. Manufacturer recommendations for milk analysis will be strictly followed.