Targeted Fortification of Donor Breast Milk in Preterm Infants

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 9, 2020

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Prematurity; ExtremeFailure to Thrive in NewbornGrowth RetardationGrowth FailureInfant Nutrition Disorders
Interventions
DIETARY_SUPPLEMENT

Similac 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_SUPPLEMENT

Similac 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_SUPPLEMENT

Nestle Microlipid

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_SUPPLEMENT

Medica 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_SUPPLEMENT

Similac 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_SUPPLEMENT

Similac 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_SUPPLEMENT

Nestle 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_SUPPLEMENT

Medica 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

OTHER

Analysis 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.

Trial Locations (1)

10032

RECRUITING

Columbia University Medical Center/ New York - Presbyterian, New York

All Listed Sponsors
lead

Columbia University

OTHER