Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
127 participants
INTERVENTIONAL
2014-08-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Bovine protein-based fortifier
Bovine protein-based fortifier
Human milk-based fortifier
Human milk-based fortifier
Interventions
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Human milk-based fortifier
Bovine protein-based fortifier
Eligibility Criteria
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Inclusion Criteria
* Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient
Exclusion Criteria
* \>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
2 Weeks
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Deborah O'Connor
Senior Associate Scientist, Research Institute
Principal Investigators
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Deborah L O'Connor, PhD RD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, University of Toronto
Sharon L Unger, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital, University of Toronto
Locations
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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
North York General Hospital
Toronto, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
St Joseph's Health Centre
Toronto, Ontario, Canada
Countries
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References
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Asbury MR, Shama S, Sa JY, Bando N, Butcher J, Comelli EM, Copeland JK, Forte V, Kiss A, Sherman PM, Stintzi A, Taibi A, Tomlinson C, Unger S, Wang PW, O'Connor DL; OptiMoM Feeding Group. Human milk nutrient fortifiers alter the developing gastrointestinal microbiota of very-low-birth-weight infants. Cell Host Microbe. 2022 Sep 14;30(9):1328-1339.e5. doi: 10.1016/j.chom.2022.07.011. Epub 2022 Aug 19.
Hopperton KE, Pitino MA, Walton K, Kiss A, Unger SL, O'Connor DL, Bazinet RP. Docosahexaenoic acid and arachidonic acid levels are correlated in human milk: Implications for new European infant formula regulations. Lipids. 2022 May;57(3):197-202. doi: 10.1002/lipd.12338. Epub 2022 Feb 15.
Hopperton KE, Pitino MA, Chouinard-Watkins R, Shama S, Sammut N, Bando N, Williams BA, Walton K, Kiss A, Unger SL, Bazinet RP, O'Connor DL. Determinants of fatty acid content and composition of human milk fed to infants born weighing <1250 g. Am J Clin Nutr. 2021 Oct 4;114(4):1523-1534. doi: 10.1093/ajcn/nqab222.
Hopperton KE, O'Connor DL, Bando N, Conway AM, Ng DVY, Kiss A, Jackson J, Ly L; OptiMoM Feeding Group; Unger SL. Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. Curr Dev Nutr. 2019 Nov 12;3(12):nzz129. doi: 10.1093/cdn/nzz129. eCollection 2019 Dec.
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.
Other Identifiers
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1000044263
Identifier Type: -
Identifier Source: org_study_id