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 type | Observational |
|---|---|
| Ages | 1 Hour to 21 Days |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Status | Recruiting |
| Started | October 1, 2010 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT06870981 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
- Principal investigator: Deborah L O'Connor, PhD, RN — The Hospital for Sick Children
- Study coordinator: Dubraiicka Pichardo, MSc
- Email: dubraiicka.pichardo@sickkids.ca
- Phone: 416-813-7654
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.