Bovine vs. Human Milk-Based Fortifier Study

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infant (<1250g)

• 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

Study Timeline

• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-10
• Study First Posted: 2014-05-13
• Study Start: 2014-08
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

Mackenzie Health; 🇨🇦 Richmond Hill, Ontario, Canada

Rouge Valley Health System; 🇨🇦 Toronto, Ontario, Canada

The Scarborough Hospital-General; 🇨🇦 Toronto, Ontario, Canada

The Scarborough Hospital-Birchmount; 🇨🇦 Toronto, Ontario, Canada

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