Actively Recruiting
Optimizing Nutrition and Milk (Opti-NuM) Project
Led by The Hospital for Sick Children · Updated on 2025-03-11
1100
Participants Needed
6
Research Sites
895 weeks
Total Duration
On this page
Sponsors
T
The Hospital for Sick Children
Lead Sponsor
M
Mount Sinai Hospital, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Optimizing Nutrition and Milk (Opti-NuM) Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs
You will not qualify if you...
- Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Stanford University
Palo Alto, California, United States, 94304-1212
Active, Not Recruiting
2
University of California - San Diego
San Diego, California, United States, 92093-0715
Active, Not Recruiting
3
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Active, Not Recruiting
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
5
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 0A4
Active, Not Recruiting
6
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
Research Team
D
Dubraiicka Pichardo, MSc
CONTACT
A
Aneta Plaga, BSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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