Very Low Birth Weight Infant (<1250g)
Conditions
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.
Interventions
OTHERHuman milk-based fortifier
OTHERBovine protein-based fortifier
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 |
| 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) |
Countries
Canada
Outcome results
None listed