Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 21 days
Healthy Volunteers: f
View:

• • Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs

Locations
United States
California
Stanford University
ACTIVE_NOT_RECRUITING
Palo Alto
University of California - San Diego
ACTIVE_NOT_RECRUITING
San Diego
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
The Hospital for Sick Children
ACTIVE_NOT_RECRUITING
Toronto
University of Manitoba
ACTIVE_NOT_RECRUITING
Winnipeg
Contact Information
Primary
Dubraiicka Pichardo, MSc
dubraiicka.pichardo@sickkids.ca
416-813-7654
Backup
Aneta Plaga, BSc
aneta.plaga@utoronto.ca
416-978-2422
Time Frame
Start Date: 2010-10-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 1100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children
Collaborators: University of California, San Diego, University of Manitoba, Stanford University, University of Toronto, Mount Sinai Hospital, Canada, Sunnybrook Health Sciences Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov