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Bovine vs. Human Milk-Based Fortifier Study

NCT02137473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2021-11-26

No results posted yet for this study

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.

Conditions

  • Very Low Birth Weight Infant (<1250g)

Interventions

OTHER

Human milk-based fortifier

OTHER

Bovine protein-based fortifier

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Deborah L O'Connor, PhD RD · The Hospital for Sick Children, University of Toronto

  • Sharon L Unger, MD FRCPC · Mount Sinai Hospital, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137473 on ClinicalTrials.gov