Very Low Birth Weight Infant (<1250g) Clinical Trial
Official title:
Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study
| NCT number | NCT02137473 |
| Other study ID # | 1000044263 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2014 |
| Est. completion date | March 2016 |
| Verified date | November 2021 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 127 |
| Est. completion date | March 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 2 Weeks |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | William Osler Health System-Brampton | Brampton | Ontario |
| Canada | William Osler Health System-Etobicoke | Etobicoke | Ontario |
| Canada | Izaak Walton Killam Health Centre | Halifax | Nova Scotia |
| 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 | Humber River Hospital | Toronto | Ontario |
| Canada | Mount Sinai Hospital | Toronto | Ontario |
| Canada | North York General Hospital | Toronto | Ontario |
| Canada | Rouge Valley Health System | Toronto | Ontario |
| Canada | St Joseph's Health Centre | Toronto | Ontario |
| Canada | St Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Canada | The Scarborough Hospital-Birchmount | Toronto | Ontario |
| Canada | The Scarborough Hospital-General | Toronto | Ontario |
| Canada | Toronto East General Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Other measures of feeding tolerance | 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) | 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 | |
| Other | 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 | ||
| Other | Morbidity/mortality composite | Necrotizing enterocolitis, late onset sepsis, chronic lung disease, severe retinopathy of prematurity, death | 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 | |
| Other | Bayley Scales of Infant and Toddler Development (BSID)-III | Cognitive, language and motor development as assessed by the BSID-III | 18-24 months corrected age | |
| Other | Gut microbiota | 56 days of age or hospital discharge | ||
| Primary | 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 | 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 | |
| Secondary | Growth | Daily weight measurements, weekly length measurements, weekly head circumference measurements, z-scores for anthropometric measures | 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 |