Bovine vs. Human Milk-Based Fortifier Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bovine protein-based fortifier
|
Other: Bovine protein-based fortifier
|
| Experimental: Human milk-based fortifier
|
Other: Human milk-based fortifier
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- Other measures of 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]
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)
- Gut inflammation [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 [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
- Bayley Scales of Infant and Toddler Development (BSID)-III [18-24 months corrected age]
Cognitive, language and motor development as assessed by the BSID-III
- Gut microbiota [56 days of age or hospital discharge]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Izaak Walton Killam Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 2 | William Osler Health System-Brampton | Brampton | Ontario | Canada | L6R 3J7 |
| 3 | William Osler Health System-Etobicoke | Etobicoke | Ontario | Canada | M9V 1R8 |
| 4 | Markham Stouffville Hospital | Markham | Ontario | Canada | L3P 7P3 |
| 5 | Southlake Regional Health Centre | Newmarket | Ontario | Canada | L3Y 2P9 |
| 6 | Lakeridge Health | Oshawa | Ontario | Canada | L1G 2B9 |
| 7 | Mackenzie Health | Richmond Hill | Ontario | Canada | L4C 4Z3 |
| 8 | Rouge Valley Health System | Toronto | Ontario | Canada | M1E 4B9 |
| 9 | The Scarborough Hospital-General | Toronto | Ontario | Canada | M1P 2V5 |
| 10 | The Scarborough Hospital-Birchmount | Toronto | Ontario | Canada | M1W 3W3 |
| 11 | North York General Hospital | Toronto | Ontario | Canada | M2K 1E1 |
| 12 | Humber River Hospital | Toronto | Ontario | Canada | M3N 1N1 |
| 13 | Toronto East General Hospital | Toronto | Ontario | Canada | M4C 3E7 |
| 14 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 15 | St Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 16 | Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
| 17 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 18 | St Joseph's Health Centre | Toronto | Ontario | Canada | M6R 1B5 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1000044263