NCT06870981 Optimizing Nutrition and Milk (Opti-NuM) Project
| NCT ID | NCT06870981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Very Low Birth Weight Baby |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2010-10-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2010-10-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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.
Contact & Investigator
Deborah L O'Connor, PhD, RN
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT06870981 clinical trial?
This trial is open to participants of all sexes, aged 1 Hour or older, up to 21 Days, studying Very Low Birth Weight Baby. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06870981 currently recruiting?
Yes, NCT06870981 is actively recruiting participants. Contact the research team at dubraiicka.pichardo@sickkids.ca for enrollment information.
Where is the NCT06870981 trial being conducted?
This trial is being conducted at Palo Alto, United States, San Diego, United States, Winnipeg, Canada, Toronto, Canada and 2 additional locations.
Who is sponsoring the NCT06870981 clinical trial?
NCT06870981 is sponsored by The Hospital for Sick Children. The principal investigator is Deborah L O'Connor, PhD, RN at The Hospital for Sick Children. The trial plans to enroll 1,100 participants.