ClinicalTrials.gov
ClinicalTrials.gov Menu

Bovine vs. Human Milk-Based Fortifier Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02137473
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah O'Connor, 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, gut microbiome, and neonatal morbidity and mortality.

Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infant (<1250g) Other: Human milk-based fortifier Other: Bovine protein-based fortifier Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study
Actual Study Start Date : August 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Active Comparator: Bovine protein-based fortifier Other: Bovine protein-based fortifier
Experimental: Human milk-based fortifier Other: Human milk-based fortifier



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137473


Locations
Canada, Nova Scotia
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
William Osler Health System-Brampton
Brampton, Ontario, Canada, L6R 3J7
William Osler Health System-Etobicoke
Etobicoke, Ontario, Canada, M9V 1R8
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7P3
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Mackenzie Health
Richmond Hill, Ontario, Canada, L4C 4Z3
Rouge Valley Health System
Toronto, Ontario, Canada, M1E 4B9
The Scarborough Hospital-General
Toronto, Ontario, Canada, M1P 2V5
The Scarborough Hospital-Birchmount
Toronto, Ontario, Canada, M1W 3W3
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Humber River Hospital
Toronto, Ontario, Canada, M3N 1N1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
St Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Deborah L O'Connor, PhD RD The Hospital for Sick Children, University of Toronto
Principal Investigator: Sharon L Unger, MD FRCPC Mount Sinai Hospital, University of Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah O'Connor, Senior Associate Scientist, Research Institute, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02137473     History of Changes
Other Study ID Numbers: 1000044263
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms