ClinicalTrials.gov
ClinicalTrials.gov Menu

Infant Nutrition and Brain Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03111927
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels will be compared and a breastfed group will be considered as epidemiological reference.

Condition or disease Intervention/treatment Phase
Healthy Infant Development Other: Infant Formula: enriched level of myelin-relevant nutrients Other: Infant formula: standard level of myelin-relevant nutrients Not Applicable

Detailed 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 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 evaluations of general cognitive and social-emotional development.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multicenter, double blind, randomized, controlled, parallel group, adaptive group sequential 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 infants

Masking: 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
Official Title: The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Reference Arm: Breastfed
Epidemiological reference group of breastfed infants.
Experimental: Investigational
Infant Formula: enriched level of myelin-relevant nutrients
Other: Infant Formula: enriched level of myelin-relevant nutrients

Feeding with the assigned infant formula can begin as soon as the child is enrolled in the study (from 2 weeks up to 5 weeks of life) and will last up 12 months of age (+/- 2 weeks).

The volume of feed required by the child per day will depend upon age, weight, and appetite. The product should be given daily ad libitum to the child from enrollment up to 12 months.

Other Name: Infant Formula

Active Comparator: Control
Infant formula: standard level of myelin-relevant nutrients
Other: Infant formula: standard level of myelin-relevant nutrients

Feeding with the assigned infant formula can begin as soon as the child is enrolled in the study (from 2 weeks up to 5 weeks of life) and will last up 12 months of age (+/- 2 weeks).

The volume of feed required by the child per day will depend upon age, weight, and appetite. The product should be given daily ad libitum to the child from enrollment up to 12 months.

Other Name: Infant Formula




Primary Outcome Measures :
  1. Myelin content, Magnetic Resonance Imaging (MRI, physiological marker) [ Time Frame: 24 months of life ]
    Myelin content comparison between the 2 nutrient blend groups assessed by a brain magnetic resonance imaging (MRI, multicomponent relaxometry) derived measure of myelin content in the brain (myelin water fraction) [Physiological marker, MRI].


Secondary Outcome Measures :
  1. Brain Myelination, Longitudinal analysis [ Time Frame: 3, 6, 12, 18, and 24 months of life ]
    Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). [Physiological marker, MRI].

  2. Brain Myelination, Cross sectional analysis [ Time Frame: 3, 6, 12, 18, and 24 months of life ]
    Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). [Physiological marker, MRI].

  3. Brain structure [ Time Frame: 3, 6, 12, 18, and 24 months of life ]
    Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) [Physiological marker, MRI].

  4. Brain connectivity [ Time Frame: 3, 6, 12, 18 and 24 months of life ]
    Brain magnetic resonance imaging (MRI) derived measures of functional connectivity (Diffusion Tensor Imaging = DTI, resting state functional MRI = rsFMRI) [Physiological marker, MRI].

  5. Infant Cognitive Development [ Time Frame: 6, 12, and 24 months of life ]
    Standardized neurodevelopment test.

  6. Infant Early Learning Assessment [ Time Frame: 18 and 24 months of life ]
    Computer-based cognitive tasks.

  7. Infant Social Emotional Development [ Time Frame: 3, 6, 12, 18, and 24 months of life ]
    Parent report questionnaire.

  8. Infant dietary assessment [ Time Frame: 6, 9, 12, 18, and 24 months of life ]
    Three days food records are planned at the specified time-frames.

  9. Breast milk nutrients profile [ Time Frame: week 3, week 6, and 3 months of life ]
    Nutrients (vitamins, minerals, and other nutrients) levels analyses in breast milk nutrients (subsample) [Physiological parameter].



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term infants (≥ 38 weeks)
  • Neuro typical development
  • No major risk factors for learning, neurologic, or psychiatric disorder
  • Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.

Exclusion Criteria:

  • Delayed birth (> 41 weeks gestation)
  • Birth Weight < 2500 g or small for gestation age or large for gestational age
  • Psychopharmacological treatment of mother using prohibited medications during pregnancy
  • Multiple birth
  • Abnormalities on fetal ultrasound
  • Complicated pregnancy
  • APGAR scores less than 8
  • Neonatal intensive care unit admission and/or emergency surgical delivery
  • Abnormal screening laboratory values and studies considered to be clinically significant in the opinion of the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111927


Contacts
Contact: Mirna Del Valle (973) 593-7749 Mirna.DelValle@rd.nestle.com

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Rachel Dabek    617-919-7355    rachel.dabek@childrens.harvard.edu   
Principal Investigator: P. Ellen Grant, MD         
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Gretchen Sloane, BSN    401-338-6943    baby.imaging.lab@gmail.com   
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Sean Deoni, PhD Memorial Hospital of Rhode Island
Study Director: Viren D'Sa, MD Memorial Hospital of Rhode Island

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03111927     History of Changes
Other Study ID Numbers: 16.14.NRC
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: MRI scans will be shared between sites. No Personal Identifiable Information will be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nestlé:
Nutrition, Brain Development, Cognition, Heathy Infants