Bovine vs. Human Milk-Based Fortifier Study

November 23, 2021 updated by: Deborah O'Connor, The Hospital for Sick Children

Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study

Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. Adding nutrients to human milk improves their nutritional status and growth, but it is unclear if adding bovine protein-based fortifiers as is the current standard of care has some unintended negative consequences to neonates. Infants will be randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to assess feeding tolerance, growth, gut inflammation, mother's milk and infant gut microbiome, and neonatal morbidity and mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

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 Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Izaak Walton Killam Health Centre
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System-Brampton
      • Etobicoke, Ontario, Canada, M9V 1R8
        • William Osler Health System-Etobicoke
      • Markham, Ontario, Canada, L3P 7P3
        • Markham Stouffville Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health
      • Richmond Hill, Ontario, Canada, L4C 4Z3
        • Mackenzie Health
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
      • Toronto, Ontario, Canada, M1E 4B9
        • Rouge Valley Health System
      • Toronto, Ontario, Canada, M1P 2V5
        • The Scarborough Hospital-General
      • Toronto, Ontario, Canada, M1W 3W3
        • The Scarborough Hospital-Birchmount
      • Toronto, Ontario, Canada, M3N 1N1
        • Humber River Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St Joseph's Health Centre

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

No older than 2 weeks (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • <1250g birth weight
  • Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient

Exclusion Criteria:

  • Infant receives formula or a nutrient fortifier prior to randomization
  • >day 14 at the time of enrollment and enteral feeds have not commenced
  • Infants with major congenital or chromosomal anomalies that could impact growth
  • Enrollment in another research study affecting nutritional management during the feeding intervention
  • Reasonable potential that the infant will be transferred to a neonatal intensive care unit where the study protocol will not be continued

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bovine protein-based fortifier
Other: Bovine protein-based fortifier
Experimental: Human milk-based fortifier
Other: Human milk-based fortifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding tolerance
Time Frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Percentage of infants with a significant feeding interruption as defined by days feedings held for ≥12 hours OR feeds reduced by >50% (ml/kg/d) not due to a clinical procedure or transitioning to the breast
84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Daily weight measurements, weekly length measurements, weekly head circumference measurements, z-scores for anthropometric measures
84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other measures of feeding tolerance
Time Frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Percent and number of days of emesis, gastric aspirates >50% pre-feed volume, abdominal distension (>2 cm), percentage of infants where enteral feeding was terminated and parenteral nutrition had to be commenced, some assessment of the interruption of feeds, how long it takes to reach full enteral feeds (150 ml/kg/d)
84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Gut inflammation
Time Frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Morbidity/mortality composite
Time Frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Necrotizing enterocolitis, late onset sepsis, chronic lung disease, severe retinopathy of prematurity, death
84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Bayley Scales of Infant and Toddler Development (BSID)-III
Time Frame: 18-24 months corrected age
Cognitive, language and motor development as assessed by the BSID-III
18-24 months corrected age
Gut microbiota
Time Frame: 56 days of age or hospital discharge
56 days of age or hospital discharge

Collaborators and Investigators

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

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Deborah L O'Connor, PhD RD, The Hospital for Sick Children, University of Toronto
  • Principal Investigator: Sharon L Unger, MD FRCPC, Mount Sinai Hospital, University of Toronto

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)

August 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 10, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000044263

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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