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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
127
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
...and 8 more locations
Feeding tolerance
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
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
Growth
Daily weight measurements, weekly length measurements, weekly head circumference measurements, z-scores for anthropometric measures
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
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