Recruiting

Nutrition

Sponsor:

The Hospital for Sick Children

Code:

NCT06870981

Conditions

Very Low Birth Weight Baby

Early Nutrition and the Preterm Infant

Nutritional Requirements

Human Milk Fortification

Human Milk Microbiome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

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.

Study Details

Brief 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

Study ID

NCT06870981

Start date

Oct 1, 2010

Status verified date

Mar, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants of the MaxiMoM Platform Trials

Secondary data use and biospecimens from participants of the MaxiMoM Platform Trials are infants born 1500g or less (infant weight), born in the Greater Toronto Area.

Interventions

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.

Primary outcome measure

  • Cognitive composite score on the Bayley Scales of Infant and Toddler Development. [ Time Frame: At 18-24 months CA ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Eugene Ng, MD, FRCPC, FAAP

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Principal Investigator:

Sharon L Unger, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

  • Very Low Birth Weight Infants
  • Early nutrition and the preterm infant
  • Human milk feeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-03-11.