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).
Observational study mode: The Opti-NuM Project is a retrospective secondary data/sample use study. Time perspective: Secondary use data and biospecimens accruing from the 2 completed studies DoMINO and OptiMOM (NCT02137473) and 1 ongoing RCT MaxiMoM (NCT05308134) are included in this project. Sampling method: This project is a secondary use of data/samples, from a cohort consisting of participants of the MaxiMoM Platform RCTs.
Study Type
OBSERVATIONAL
Enrollment
1,100
Stanford University
Palo Alto, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California - San Diego
San Diego, California, United States
ACTIVE_NOT_RECRUITINGUniversity of Manitoba
Winnipeg, Manitoba, Canada
ACTIVE_NOT_RECRUITINGSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGThe Hospital for Sick Children
Toronto, Ontario, Canada
ACTIVE_NOT_RECRUITINGMount Sinai Hospital
Toronto, Ontario, Canada
RECRUITINGCognitive composite score on the Bayley Scales of Infant and Toddler Development.
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.
Time frame: At 18-24 months CA
Language composite score from the Bayley Scales of Infant and Toddler Development
Language composite score from the Bayley Scales of Infant and Toddler Development. 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.
Time frame: At 18-24 months CA
Motor composite score from the Bayley Scales of Infant and Toddler Development
Motor composite score from the Bayley Scales of Infant and Toddler Development. 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.
Time frame: At 18-24 months CA
Weight (g)
Weight gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Daily weights are prospectively extracted from medical records.
Time frame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Length (cm)
Length gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Weekly length is determined by research staff using length boards and standardized procedures.
Time frame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Head circumference (cm)
Head circumference (HC) gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Weekly HC measurements are determined by research staff using non-stretchable tape measures and standardized procedures.
Time frame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Serious morbidities
Serious morbidities including late-onset sepsis (\>day 5, positive blood or cerebrospinal fluid culture), NEC (Bell stage ≥II), chronic lung disease (respiratory support at 36 weeks) and retinopathy of prematurity requiring treatment are collected prospectively from the medical chart.
Time frame: During hospital stay, an average of 60 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.