Back to Trials
NCT06870981Recruiting

Optimizing Nutrition and Milk (Opti-NuM) Project

The Hospital for Sick Children

Start Date

10/1/2010

Completion Date

12/1/2027

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).

Detailed Description

Observational study mode: 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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: • Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs Exclusion Criteria: • Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.

Interventions

OTHER

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.

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Very Low Birth Weight BabyEarly Nutrition and the Preterm InfantNutritional RequirementsHuman Milk FortificationHuman Milk MicrobiomeHuman Milk FeedingHuman Milk NutritionGrowth &Amp; Development

Locations

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