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NCT06870981 · ClinicalTrials.gov registry record
Optimizing Nutrition and Milk (Opti-NuM) Project
A clinical trial of Growth & Development and Very Low Birth Weight Baby, sponsored by The Hospital for Sick Children.
- Recruiting
- Registry status
- 1,100
- Enrollment target
- 6
- Study locations
NCT06870981: Recruiting study of Growth & Development and Very Low Birth Weight Baby, sponsored by The Hospital for Sick Children.
NCT06870981 is a study of Growth & Development and Very Low Birth Weight Baby that is actively recruiting participants, run by The Hospital for Sick Children. The registered enrollment target is 1,100 participants. The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06870981, a study of Growth & Development and Very Low Birth Weight Baby, is actively recruiting participants, sponsored by The Hospital for Sick Children.
- RECRUITING
- Registry status
- 1,100 participants
- Enrollment target
- 6
- Study locations
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).
Primary Outcome
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
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 |
What NCT06870981 shows while recruiting
NCT06870981 is an observational study that tracks outcomes without assigning an intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus.
The record links to 8 conditions, with Growth & Development 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.
NCT06870981 lists 6 locations in 3 states (Ontario, California, Manitoba).
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: Growth & Development, Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification.
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).
Who is sponsoring clinical trial NCT06870981?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
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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