RECRUITING

Optimizing Nutrition and Milk (Opti-NuM) Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2010-10-01
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06870981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Hour to 21 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Dubraiicka Pichardo, MSc
CONTACT
416-813-7654
dubraiicka.pichardo@sickkids.ca
Aneta Plaga, BSc
CONTACT
416-978-2422
aneta.plaga@utoronto.ca

Principal Investigator

Deborah L O'Connor, PhD, RN
PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children

Study Locations (Sites)

Stanford University
Palo Alto, California, 94304-1212
United States
University of California - San Diego
San Diego, California, 92093-0715
United States

Collaborators and Investigators

Sponsor: The Hospital for Sick Children

  • Deborah L O'Connor, PhD, RN, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-10-01
Study Completion Date2027-12

Study Record Updates

Study Start Date2010-10-01
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Very Low Birth Weight Infants
  • Early nutrition and the preterm infant
  • Human milk feeding

Additional Relevant MeSH Terms

  • 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 & Development