Optimizing Nutrition and Milk (Opti-NuM) Project for Very Low Birth Weight Babies
The Opti-NuM Project is an observational study looking at how early nutrition affects the growth and brain development of babies born with very low birth weight (VLBW). Researchers will analyze existing information and samples from other studies (MaxiMoM platform RCTs) to understand which parts of human milk are most important for these babies. They want to see how factors like parents' health, baby's genetics, and gut bacteria might influence the link between nutrition and a baby's health. The main goal is to see how nutrition affects a baby's thinking and learning skills at 18-24 months of age. This study does not involve new treatments; it uses information already collected from babies aged 1 hour to 21 days who were part of the MaxiMoM platform studies.
- Study design
- This is an observational study, meaning researchers will analyze existing data and samples from about 1100 participants of other studies. It is not a study where new treatments are given.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome (cognitive composite score) is measured when babies are 18-24 months old.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Optimizing Nutrition and Milk (Opti-NuM) Project
At a glance
Conditions
NCT06870981
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mount Sinai Hospital
Toronto, Ontario, Canadastudy coordinator listed
Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canadastudy coordinator listed
Recruiting
Stanford University
Palo Alto, Californiano site contact published
Active, not recruiting
The Hospital for Sick Children
Toronto, Ontario, Canadano site contact published
Active, not recruiting
University of California - San Diego
San Diego, Californiano site contact published
Active, not recruiting
University of Manitoba
Winnipeg, Manitoba, Canadano site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Deborah L O'Connor, PhD, RN · PRINCIPAL_INVESTIGATOR · The Hospital for Sick Children
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Cognitive composite score on the Bayley Scales of Infant and Toddler Development.At 18-24 months CA
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 mean of 100 with a standard deviation of 15. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.