Targeted Fortification of Donor Breast Milk in Preterm Infants

September 16, 2022 updated by: Columbia University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast milk is the best food for premature infants due to its ability to protect infants from necrotizing enterocolitis (NEC) and late onset sepsis. When a premature infant's mother's own milk supply is not enough to provide all the milk that her premature infant needs, donated breast milk is the next best option. One of the downsides of donor breast milk is that it often does not contain as much nutrition for the developing infant compared to the milk of a mother of a premature infant. This means a higher likelihood for poor growth in infant receiving mostly donor breast milk compared to mom's own milk. Due to an inability to easily measure the nutritional content of donor breast milk, standard practice has been to assume that the milk has a certain amount of fat, carbohydrates, and protein. Based on these assumptions, a set amount of additional nutritional fortifier is added to both donor and mom's own breast milk prior to it being given to the infant. Studies show that there is often less nutrition in the donor breast milk to start with than assumed. Technology is now available which uses a small volume sample to measure fat, protein, and carbohydrates in human milk, and hence, calculate the calories in the milk. Using this technology, in this study, the investigators will customize the fortification of donor breast milk by first measuring what is in the milk and then adding any additional fortification that is needed to reach the recommended goals for fat, protein, and carbohydrates. The investigators hypothesize that infants receiving this customized milk, so-called "target" fortified donor breast milk, will have better growth than infants receiving the standard amount of fortification added to their donor breast milk.

The study design involves measurement of macronutrient and calorie content of donor breast milk using a point-of-care human milk analyzer (Miris, AB). The individual macronutrient (protein, fat, and carbohydrate) concentrations will be targeted in the intervention group such that the infant will receive protein of 4 g/kg/day, fat of 6.6 g/kg/day, and carbohydrates of 11.6-13.2 g/kg/day. Fortification will be added in a step-wise fashion daily over a 3-4 day period starting when the infant reaches about 80 ml/kg/day in feeding volume. Fortifiers that may be used in this study include: Abbott Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Abbott Liquid Protein, Nestle Microlipid, and Medica Nutrition SolCarb. Participants in the control arm will receive donor milk that is fortified in the standard fashion at this institution; that is, 4 packets of Human Milk Fortifier will be added to 100 ml of donor breast milk. Additional fortification such as liquid protein or microlipid may be added to the donor milk and mom's own milk in response to poor growth for participants in both groups, as is standard of care in this Neonatal Intensive Care Unit (NICU). Patients in both experimental and control groups will always receive mom's own milk first when it is available. Mom's own milk will not be analyzed and will always be fortified in the standard fashion for both groups. The participants will be studied until they reach 34 weeks corrected gestational age.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/ New York - Presbyterian
        • Contact:
        • Principal Investigator:
          • Marianne Garland, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Standard fortification of breast milk
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.
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.
Experimental: Experimental
Targeted fortification of 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Up to 11 weeks
Weight change in g/kg/day, z-score value, and change in z-score from week-to-week
Up to 11 weeks
Change in length
Time Frame: Up to 11 weeks
Length change in cm/kg/day, z-score value, and change in z-score from week-to-week
Up to 11 weeks
Head circumference
Time Frame: Up to 11 weeks
Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week
Up to 11 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Days of Length of Stay in NICU
Time Frame: Up to 1 year
Today number of days in the NICU.
Up to 1 year
Rate of Mortality
Time Frame: Up to one year
Rate of morality during NICU hospitalization.
Up to one year
Number of Feeding Intolerance Events
Time Frame: Up to 34 weeks corrected gestational age
The number of feeding intolerance events, defined as 1 or more feeds held.
Up to 34 weeks corrected gestational age
Number of Necrotizing Enterocolitis Events
Time Frame: Up to 1 year of age
Number of necrotizing enterocolotis events.
Up to 1 year of age
Incidence of Bronchopulmonary dysplasia
Time Frame: Up to 1 year of age
Incidence of supplemental oxygen requirement at 36 weeks corrected gestational age.
Up to 1 year of age
Incidence of Retinopathy of prematurity
Time Frame: Up to 1 year of age
Incidence of retinopathy of prematurity
Up to 1 year of age
Percentage of Feeds with Donor Milk and Mother's Milk
Time Frame: Up to 34 weeks corrected gestational age
Percent of feeds that are donor milk and mom's own milk.
Up to 34 weeks corrected gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Marianne Garland, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS6625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data (IPD) may be shared with other researchers at Columbia University Medical Center at the end of the study for the purposes of creating a neurodevelopmental follow-up study that involves following participants in the study until they reach 2 years (corrected post-natal age) in neurodevelopment follow-up clinic. Permission for future contact is included in the consent form for participants in this study. Only participants who consent to future contact will be approached about a neurodevelopmental follow-up study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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