Optimizing Nutrition and Milk (Opti-NuM) Project

Recruiting now

Conditions studied: Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification, Human Milk Microbiome, Human Milk Feeding, Human Milk Nutrition, Growth &Amp; Development

In brief

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).

Key facts

Study ID: NCT06870981
Run by: The Hospital for Sick Children
People needed: 1100
Starts: 2010-10-01
Expected to finish: 2027-12-01
Last updated by the study team: 2025-03-11

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)
Stanford University — Palo Alto, California, United States
University of California - San Diego — San Diego, California, United States
University of Manitoba — Winnipeg, Manitoba, Canada
The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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