Optimizing nutrition for very low birth weight infants
Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project
The Hospital for Sick Children · NCT06870981
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 |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 1 Hour to 21 Days |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 6 sites (Palo Alto, California and 5 other locations) |
| Trial ID | NCT06870981 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not part of the MaxiMoM Platform RCTs will not benefit from this study.
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 performed: Previous studies have shown promise in personalized nutrition approaches for preterm infants, suggesting potential for success in this novel observational study.
Eligibility criteria
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 this trial is running
Palo Alto, California and 5 other locations
- 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)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
- The Hospital for Sick Children — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
- Mount Sinai Hospital — Toronto, Ontario, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification, Human Milk Microbiome, Human Milk Feeding, Human Milk Nutrition, Growth &Amp