Recruiting

Fortified Donor Milk

Sponsor:

Columbia University

Code:

NCT04294368

Conditions

Prematurity; Extreme

Failure to Thrive in Newborn

Growth Retardation

Growth Failure

Infant Nutrition Disorders

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid

Similac Liquid Protein Fortifier

Nestle Microlipid

Medica Nutrition SolCarb

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

Study Details

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.

Conditions

Prematurity; Extreme

Failure to Thrive in Newborn

Growth Retardation

Growth Failure

Infant Nutrition Disorders

Study ID

NCT04294368

Start date

Mar 9, 2020

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Control

Standard fortification of breast milk

experimental: Experimental

Targeted fortification of breast milk

Interventions

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.

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.

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.

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.

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.

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.

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

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

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.

Primary outcome measure

  • Change in weight [ Time Frame: Up to 11 weeks ]
  • Change in length [ Time Frame: Up to 11 weeks ]
  • Head circumference [ Time Frame: Up to 11 weeks ]

Central Contacts and Locations

Central contacts

Marianne Garland, MD

212 305 0952mg71@cumc.columbia.edu

Locations

Columbia University Medical Center/ New York - Presbyterian

Recruiting

New York, New York, United States, 10032

Contacts

Marianne Garland, MD

mg71@cumc.columbia.edu

Principal Investigator:

Marianne Garland, MD

More Information

Sponsor

Columbia University

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • Human Milk Analyzer
  • Miris
  • Target Fortification
  • Targeted Fortification
  • Donor Breast Milk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-07.