Bovine vs. Human Milk-Based Fortifier Study

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study

Conditions
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Very Low Birth Weight Infant (<1250g)

Intervention / Treatment
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* Other: Human milk-based fortifier
* Other: Bovine protein-based fortifier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bovine protein-based fortifier<br> | Other: Bovine protein-based fortifier<br> <br> |
| Experimental: Human milk-based fortifier<br> | Other: Human milk-based fortifier<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |