Optimizing Nutrition and Milk (Opti-NuM) Project

Last updated: March 6, 2025
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diet And Nutrition

Treatment

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.

Clinical Study ID

NCT06870981
4842
5R01HD111018-03
  • Ages 1-21
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs

Exclusion

Exclusion Criteria:

• Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: 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.
Phase:
Study Start date:
October 01, 2010
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • University of Manitoba

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 0A4
    Canada

    Site Not Available

  • Stanford University

    Palo Alto, California 94304-1212
    United States

    Site Not Available

  • University of California - San Diego

    San Diego, California 92093-0715
    United States

    Site Not Available

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