Skip to main content
OpenTrials
Completed

NCT Number: NCT02137473

Bovine vs. Human Milk-Based Fortifier Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Very Low Birth Weight Infant (<1250g)

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izaak Walton Killam Health Centre, Halifax, Nova Scotia, Canada

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human milk-based fortifier

Other

Bovine protein-based fortifier

Other

Primary outcomes

  1. Feeding tolerance

    Time frame: 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 outcomes

  1. Growth

    Time frame: 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 outcomes

  1. Other measures of feeding tolerance

    Time frame: 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)

  2. Gut inflammation

    Time frame: 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

  3. Morbidity/mortality composite

    Time frame: 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

  4. Bayley Scales of Infant and Toddler Development (BSID)-III

    Time frame: 18-24 months corrected age

    Cognitive, language and motor development as assessed by the BSID-III

  5. Gut microbiota

    Time frame: 56 days of age or hospital discharge

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 13, 2014
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.