Optimizing Nutrition and Milk (Opti-NuM) Project

Conditions

• Early Nutrition and the Preterm Infant
• Growth &Amp; Development
• Human Milk Feeding
• Human Milk Fortification
• Human Milk Microbiome
• Human Milk Nutrition
• Nutritional Requirements
• Very Low Birth Weight Baby

Eligibility Criteria

Sex

ALL

Age

1 Hour - 21 Days

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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).

Key Dates

Start date

Oct 1, 2010

Status verified

Mar 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

1,100 participants (estimated)

Arms

• Arm: Participants of the MaxiMoM Platform Trials
  Secondary data use and biospecimens from participants of the MaxiMoM Platform Trials are infants born 1500g or less (infant weight), born in the Greater Toronto Area.

Primary Outcome Measure

Cognitive composite score on the Bayley Scales of Infant and Toddler Development. [ Time Frame: At 18-24 months CA ]

Central Contacts

• Dubraiicka Pichardo, MSc
  416-813-7654
  [email protected]
• Aneta Plaga, BSc
  416-978-2422
  [email protected]

Locations (2)

Find similar trials in Palo Alto, CA