Actively Recruiting

Age: 1Hour - 21Days
All Genders
NCT06870981

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

Age: 1Hour - 21Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs
Not Eligible

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

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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

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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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