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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RECRUITING
1100 participants
OBSERVATIONAL
2010-10-01
2027-12-31
Brief Summary
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The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program\* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).
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Detailed Description
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The Opti-NuM Project is a retrospective secondary data/sample use study.
Time perspective:
Secondary use data and biospecimens accruing from the 2 completed studies DoMINO and OptiMOM (NCT02137473) and 1 ongoing RCT MaxiMoM (NCT05308134) are included in this project.
Sampling method:
This project is a secondary use of data/samples, from a cohort consisting of participants of the MaxiMoM Platform RCTs.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants of the MaxiMoM Platform Trials
Secondary data use and biospecimens from participants of the MaxiMoM Platform Trials are infants born 1500g or less (infant weight), born in the Greater Toronto Area.
Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
Interventions
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Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Hour
21 Days
ALL
No
Sponsors
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Mount Sinai Hospital, Canada
OTHER
Sunnybrook Health Sciences Centre
OTHER
University of Toronto
OTHER
University of Manitoba
OTHER
Stanford University
OTHER
University of California, San Diego
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The Hospital for Sick Children
OTHER
Responsible Party
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Deborah O'Connor
Senior Associate Scientist
Principal Investigators
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Deborah L O'Connor, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Stanford University
Palo Alto, California, United States
University of California - San Diego
San Diego, California, United States
University of Manitoba
Winnipeg, Manitoba, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
O'Connor DL, Gibbins S, Kiss A, Bando N, Brennan-Donnan J, Ng E, Campbell DM, Vaz S, Fusch C, Asztalos E, Church P, Kelly E, Ly L, Daneman A, Unger S; GTA DoMINO Feeding Group. Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1897-1905. doi: 10.1001/jama.2016.16144.
Related Links
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MaxiMoM Research Platform
Other Identifiers
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4842
Identifier Type: -
Identifier Source: org_study_id
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