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Optimizing Nutrition and Milk (Opti-NuM) Project
NCT06870981 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- OTHER 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.
Study Locations (6)
Ontario
- Sunnybrook Health Sciences Centre — Toronto
- The Hospital for Sick Children — Toronto
- Mount Sinai Hospital — Toronto
California
- Stanford University — Palo Alto
- University of California - San Diego — San Diego
Manitoba
- University of Manitoba — Winnipeg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2010-10-01 |
| Est. Completion | 2027-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06870981
The ClinicalTrials.gov registry entry for NCT06870981 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Hospital for Sick Children, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Very Low Birth Weight Baby appearing as the primary indexed condition, and to 1 intervention — of which 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. is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06870981 reports 6 study locations spanning 3 distinct geographic areas — top geographies include Ontario, California, Manitoba. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06870981 about?
NCT06870981 is a clinical study titled "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 i...
What is the current status of trial NCT06870981?
This trial is currently recruiting. The enrollment target is 1,100 participants. The study started on 2010-10-01. Estimated completion is 2027-12.
What conditions does trial NCT06870981 study?
This clinical trial studies the following conditions: Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification, Human Milk Microbiome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06870981?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06870981?
This trial is sponsored by The Hospital for Sick Children, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06870981 being conducted?
This trial has 6 study locations across California, Manitoba, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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