Optimizing Nutrition and Milk (Opti-NuM) Project
Opti-NuM
Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project
2 other identifiers
observational
1,100
2 countries
6
Brief Summary
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 11, 2025
March 1, 2025
16.2 years
February 3, 2025
March 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive composite score on the Bayley Scales of Infant and Toddler Development.
Our primary outcome is the cognitive composite score on the Bayley Scales of Infant and Toddler Development collected from the medical record or by home-visit by our research staff. The Bayley is the most widely used instrument globally by clinicians and researchers to assess developmental functioning of infants, toddlers and young children across cognitive, language (receptive, expressive) and motor (fine, gross) domains. Cognitive, language and motor composite scores will be standardized to a mean of 100 with a standard deviation of 15. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
At 18-24 months CA
Secondary Outcomes (6)
Language composite score from the Bayley Scales of Infant and Toddler Development
At 18-24 months CA
Motor composite score from the Bayley Scales of Infant and Toddler Development
At 18-24 months CA
Weight (g)
Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Length (cm)
Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Head circumference (cm)
Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
- +1 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
Very Low Birth Weight infants
You may qualify if:
- Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs
You may not qualify if:
- Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hospital for Sick Childrenlead
- Mount Sinai Hospital, Canadacollaborator
- Sunnybrook Health Sciences Centrecollaborator
- University of Torontocollaborator
- University of Manitobacollaborator
- Stanford Universitycollaborator
- University of California, San Diegocollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (6)
Stanford University
Palo Alto, California, 94304-1212, United States
University of California - San Diego
San Diego, California, 92093-0715, United States
University of Manitoba
Winnipeg, Manitoba, R3E 3P4, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 0A4, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Related Publications (2)
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.
PMID: 29878061BACKGROUNDO'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.
PMID: 27825008BACKGROUND
Related Links
Biospecimen
1. Human milk 2. Stool 3. Residual plasma 4. Buccal cells
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah L O'Connor, PhD, RN
The Hospital for Sick Children
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Associate Scientist
Study Record Dates
First Submitted
February 3, 2025
First Posted
March 11, 2025
Study Start
October 1, 2010
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- December 2024 to December 2027
- Access Criteria
- During the Opti-NuM project the following institutions will be involved in data and sample analysis as indicated. Data sharing will take place through SFTP, bio specimens will be shipped for analyses. * The Hospital for Sick Children (Lead, Deborah O'Connor PhD RD): Both data and sample analysis * The University of Toronto (Lead, Deborah O'Connor PhD RD): Both data and sample analysis * The University of Manitoba (Lead, Meghan Azad PhD): Data analysis; No sample analysis * Stanford University (Lead, Nima Aghaeepour PhD): Data analysis; No sample analysis * University of California (Lead, Lars Bode PhD): Oligosaccharide analysis of human milk samples only. No data provided to this site.
Data transfer will take place via Secure File Transfer Protocol (SFTP). Sub-agreements which cover data and sample sharing and confidentiality is in place.