Targeted Fortification of Donor Breast Milk in Preterm Infants

Conditions

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

Eligibility Criteria

Sex

ALL

Age

1 Day - 21 Days

Healthy Volunteers

Not accepted

Interventions

• Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid — DIETARY_SUPPLEMENT
  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 — DIETARY_SUPPLEMENT
  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 — DIETARY_SUPPLEMENT
  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 — DIETARY_SUPPLEMENT
  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) — DIETARY_SUPPLEMENT
  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) — DIETARY_SUPPLEMENT
  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) — DIETARY_SUPPLEMENT
  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) — DIETARY_SUPPLEMENT
  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 — OTHER
  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.

Study Details

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.

Key Dates

Start date

Mar 9, 2020

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Other: Control
  Standard fortification of breast milk
• Experimental: Experimental
  Targeted fortification of breast milk

Primary Outcome Measure

Change in weight [ Time Frame: Up to 11 weeks ]

Central Contacts

• Marianne Garland, MD
  212 305 0952
  [email protected]

Locations (1)

Find similar trials in New York, NY

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