Bovine vs. Human Milk-Based Fortifier Study
- Conditions
- Very Low Birth Weight Infant (<1250g)
- Interventions
- Other: Bovine protein-based fortifierOther: Human milk-based fortifier
- Registration Number
- NCT02137473
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- <1250g birth weight
- Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bovine protein-based fortifier Bovine protein-based fortifier - Human milk-based fortifier Human milk-based fortifier -
- Primary Outcome Measures
Name Time Method Feeding tolerance 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
- Secondary Outcome Measures
Name Time Method Growth 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
Trial Locations
- Locations (18)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
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
The Scarborough Hospital-Birchmount
🇨🇦Toronto, Ontario, Canada
Rouge Valley Health System
🇨🇦Toronto, Ontario, Canada
Mackenzie Health
🇨🇦Richmond Hill, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Humber River Hospital
🇨🇦Toronto, Ontario, Canada
The Scarborough Hospital-General
🇨🇦Toronto, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
St Joseph's Health Centre
🇨🇦Toronto, Ontario, Canada