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Bovine vs. Human Milk-Based Fortifier Study

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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

May 6, 2014
May 13, 2014
May 16, 2018
August 2014
January 2016   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02137473 on ClinicalTrials.gov Archive Site
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
Same as current
  • 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)
  • 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 ]
  • 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
  • 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
  • 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)
  • 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 ]
  • 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
 
Bovine vs. Human Milk-Based Fortifier Study
Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-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, gut microbiome, and neonatal morbidity and mortality.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Very Low Birth Weight Infant (<1250g)
  • Other: Human milk-based fortifier
  • Other: Bovine protein-based fortifier
  • Active Comparator: Bovine protein-based fortifier
    Intervention: Other: Bovine protein-based fortifier
  • Experimental: Human milk-based fortifier
    Intervention: Other: Human milk-based fortifier
O'Connor DL, Kiss A, Tomlinson C, Bando N, Bayliss A, Campbell DM, Daneman A, Francis J, Kotsopoulos K, Shah PS, Vaz S, Williams B, Unger S; OptiMoM Feeding Group. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial. Am J Clin Nutr. 2018 Jul 1;108(1):108-116. doi: 10.1093/ajcn/nqy067.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
124
March 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 2 Weeks   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT02137473
1000044263
Yes
Not Provided
Not Provided
Deborah O'Connor, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
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
The Hospital for Sick Children
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP