Clinical trial Recruiting at 2 sites Observational Ages 1 Hour to 21 Days

Optimizing nutrition for very low birth weight infants

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

Run by The Hospital for Sick Children · NCT06870981 · Data updated 2026-11-12

This study looks at how the nutrition from human milk affects the growth and health of very low birth weight infants to help create better feeding plans for them.

Quick facts

Study typeObservational
Ages1 Hour to 21 Days
SexAll
Enrollment1100 (estimated)
SponsorThe Hospital for Sick Children
Academic / other
Locations6 sites (Palo Alto, California and 5 other locations)
StatusRecruiting
StartedOctober 1, 2010
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedMarch 11, 2025
Trial IDNCT06870981 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants who were enrolled in the MaxiMoM Platform RCTs and are classified as very low birth weight.

Probably not a fit

Patients who are not part of the MaxiMoM Platform RCTs will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Opti-NuM Project focuses on understanding how early nutrition impacts the growth and development of very low birth weight (VLBW) infants. This observational study utilizes secondary data and biospecimens from previous studies to explore the relationships between human milk components, parental and infant factors, and health outcomes. By analyzing these complex interactions, the study aims to inform personalized feeding strategies that better support the nutritional needs of VLBW infants. The research emphasizes the importance of both macronutrients and bioactive components in human milk.

Why it matters

Potential benefit: If successful, this study could lead to personalized nutrition strategies that significantly improve health outcomes for very low birth weight infants.

How similar studies have gone: Previous studies have shown promise in personalized nutrition approaches for preterm infants, suggesting potential for success in this novel observational study.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting
  • Mount Sinai Hospital
    Toronto, Ontario, Canada
    Recruiting
  • Stanford University
    Palo Alto, California, United States
    Active not recruiting
  • University of California - San Diego
    San Diego, California, United States
    Active not recruiting
  • University of Manitoba
    Winnipeg, Manitoba, Canada
    Active not recruiting
  • The Hospital for Sick Children
    Toronto, Ontario, Canada
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.