Optimizing Nutrition and Milk (Opti-NuM) Project

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).

Conditions

• 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

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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Deborah L O'Connor, PhD, RN · The Hospital for Sick Children

Eligibility

Min Age

1 Hour

Max Age

21 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-01

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• United States
• Canada

Study Locations