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Study identifier: NCT06870981 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Optimizing Nutrition and Milk (Opti-NuM) Project

Condition: Very Low Birth Weight Baby · Early Nutrition and the Preterm Infant · Nutritional Requirements  ·  Sponsor: The Hospital for Sick Children

PhaseN/A
Planned participants1100
Who can joinAll sexes, 1 Hour to 21 Days
Healthy volunteersNo

About this study

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 "…

This description comes directly from the study's public registry record.

Talk to the study team

Dubraiicka Pichardo, MSc  ·  416-813-7654  ·  dubraiicka.pichardo@sickkids.ca

Aneta Plaga, BSc  ·  416-978-2422  ·  aneta.plaga@utoronto.ca

Always discuss trial participation with your own doctor first.

Locations (6)

Stanford UniversityPalo Alto, California, United StatesActive Not Recruiting
University of California - San DiegoSan Diego, California, United StatesActive Not Recruiting
University of ManitobaWinnipeg, Manitoba, CanadaActive Not Recruiting
Sunnybrook Health Sciences CentreToronto, Ontario, CanadaRecruiting
The Hospital for Sick ChildrenToronto, Ontario, CanadaActive Not Recruiting
Mount Sinai HospitalToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06870981