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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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada
William Osler Health System-Brampton
Brampton, Ontario, Canada
William Osler Health System-Etobicoke
Etobicoke, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Mackenzie Health
Richmond Hill, Ontario, Canada
Rouge Valley Health System
Toronto, Ontario, Canada
The Scarborough Hospital-General
Toronto, Ontario, Canada
The Scarborough Hospital-Birchmount
Toronto, Ontario, Canada
Start Date
August 1, 2014
Primary Completion Date
January 1, 2016
Completion Date
March 1, 2016
Last Updated
November 26, 2021
127
ACTUAL participants
Human milk-based fortifier
OTHER
Bovine protein-based fortifier
OTHER
Lead Sponsor
The Hospital for Sick Children
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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