Clinical trial NCT06870981: Optimizing Nutrition and Milk (Opti-NuM) Project
Official title: Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
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; Development
Keywords: Very Low Birth Weight Infants
Early nutrition and the preterm infant
Human milk feeding
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
name: Sunnybrook Health Sciences Centre
name: University of Toronto
name: University of Manitoba
name: Stanford University
name: University of California, San Diego
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-03-11
Enrollment: 1100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very Low Birth Weight infants

Brief 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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Cognitive composite score on the Bayley Scales of Infant and Toddler Development.
timeFrame: At 18-24 months CA
Secondary outcomes:
measure: Language composite score from the Bayley Scales of Infant and Toddler Development
timeFrame: At 18-24 months CA
measure: Motor composite score from the Bayley Scales of Infant and Toddler Development
timeFrame: At 18-24 months CA
measure: Weight (g)
timeFrame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
measure: Length (cm)
timeFrame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
measure: Head circumference (cm)
timeFrame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
measure: Serious morbidities
timeFrame: During hospital stay, an average of 60 days.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: University of California - San Diego
state: California
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Deborah L O'Connor, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor DL, Kiss A, Tomlinson C, Bando N, Bayliss A, Campbell DM, Daneman A, Francis J, Kotsopoulos K, Shah PS, Vaz S, Williams B, Unger S; OptiMoM Feeding Group. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial. Am J Clin Nutr. 2018 Jul 1;108(1):108-116. doi: 10.1093/ajcn/nqy067.
citation: O'Connor DL, Gibbins S, Kiss A, Bando N, Brennan-Donnan J, Ng E, Campbell DM, Vaz S, Fusch C, Asztalos E, Church P, Kelly E, Ly L, Daneman A, Unger S; GTA DoMINO Feeding Group. Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1897-1905. doi: 10.1001/jama.2016.16144.