Infant Nutrition and Brain Development
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 410
Summary
- Conditions
- Healthy
- Infant Development
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants. 3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infantsMasking: Double (Participant, Investigator)Masking Description: Double blind - Infant Formula arms are blinded; Reference Arm - unblinded epidemiological reference arm Allocation: Randomized for formula arms, efficacy study Primary Purpose: Basic Science
Participation Requirements
- Age
- Younger than 6 years
- Gender
- Both males and females
Description
This nutritional intervention study involves assessments in both the mother and her infant. The mother will be asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother is not breastfeeding, a study product will be provided and will be consumed by the in...
This nutritional intervention study involves assessments in both the mother and her infant. The mother will be asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother is not breastfeeding, a study product will be provided and will be consumed by the infant daily up to 12 months of life. The study also involves magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development. Once all trial subjects have completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months will be performed. Product codes (blinding) will be broken to compare groups and an appropriate operational framework will be put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.
Tracking Information
- NCT #
- NCT03111927
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sean Deoni, PhD Memorial Hospital of Rhode Island Study Director: Viren D'Sa, MD Memorial Hospital of Rhode Island
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