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Clinical Trial Summary

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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT02137473
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date March 2016