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NCT Number: NCT06870981

Optimizing Nutrition and Milk (Opti-NuM) Project

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).

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Key information

Conditions

Very Low Birth Weight Baby Early Nutrition and the Preterm Infant Growth &Amp; Development Human Milk Feeding Human Milk Fortification Human Milk Microbiome Human Milk Nutrition Nutritional Requirements

Age range

1 hour–21 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Manitoba, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other

Primary outcomes

  1. Cognitive composite score on the Bayley Scales of Infant and Toddler Development.

    Time frame: 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 outcomes

  1. Language composite score from the Bayley Scales of Infant and Toddler Development

    Time frame: 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.

  2. Motor composite score from the Bayley Scales of Infant and Toddler Development

    Time frame: 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.

  3. Weight (g)

    Time frame: 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.

  4. Length (cm)

    Time frame: 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.

  5. Head circumference (cm)

    Time frame: 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.

  6. Serious morbidities

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aneta Plaga, BSc

CONTACT

[email protected]

416-978-2422

Dubraiicka Pichardo, MSc

CONTACT

[email protected]

416-813-7654 ext. 305777

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Mount Sinai Hospital, Canada
  • Stanford University
  • Sunnybrook Health Sciences Centre
  • University of California, San Diego
  • University of Manitoba
  • University of Toronto

Registry information

Official study title

Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project

Acronym: Opti-NuM

Important dates

Study start
2010
Primary completion
2026
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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