Optimizing Nutrition and Milk (Opti-NuM) Project

Recruiting

• 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 & Development

• Registration Number: NCT06870981
• Lead Sponsor: The Hospital for Sick Children

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).

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.

Study Timeline

• Study Start: 2010-10-01
• Study First Submitted: 2025-02-03
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive composite score on the Bayley Scales of Infant and Toddler Development.	At 18-24 months CA	Our primary outcome is the cognitive composite score on the Bayley Scales of Infant and Toddler Development collected from the medical record or by home-visit by our research staff. The Bayley is the most widely used instrument globally by clinicians and researchers to assess developmental functioning of infants, toddlers and young children across cognitive, language (receptive, expressive) and motor (fine, gross) domains. Cognitive, language and motor composite scores will be standardized to a mean of 100 with a standard deviation of 15.; The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.

Secondary Outcome Measures

Name	Time	Method
Language composite score from the Bayley Scales of Infant and Toddler Development	At 18-24 months CA	Language composite score from the Bayley Scales of Infant and Toddler Development. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
Motor composite score from the Bayley Scales of Infant and Toddler Development	At 18-24 months CA	Motor composite score from the Bayley Scales of Infant and Toddler Development. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
Weight (g)	Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.	Weight gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Daily weights are prospectively extracted from medical records.
Length (cm)	Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.	Length gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Weekly length is determined by research staff using length boards and standardized procedures.
Head circumference (cm)	Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.	Head circumference (HC) gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Weekly HC measurements are determined by research staff using non-stretchable tape measures and standardized procedures.
Serious morbidities	During hospital stay, an average of 60 days.	Serious morbidities including late-onset sepsis (\>day 5, positive blood or cerebrospinal fluid culture), NEC (Bell stage ≥II), chronic lung disease (respiratory support at 36 weeks) and retinopathy of prematurity requiring treatment are collected prospectively from the medical chart.

Trial Locations

Locations (6)

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California - San Diego; 🇺🇸 San Diego, California, United States

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada