Targeted Fortification of Donor Breast Milk in Preterm Infants

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.

Conditions

• Prematurity; Extreme
• Failure to Thrive in Newborn
• Growth Retardation
• Growth Failure
• Infant 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.

Sponsors & Collaborators

• Columbia University

  lead OTHER

Principal Investigators

• Marianne Garland, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

21 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-09

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United States

Study Locations