NCT02058225

Brief Summary

The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

3.2 years

First QC Date

February 4, 2014

Last Update Submit

June 21, 2017

Conditions

Infant Development

Keywords

Infant NutritionMagnetic resonance spectroscopyInfant Brain DevelopmentDiffusion weighted ImagingDiffusion tensor tractography

Outcome Measures

Primary Outcomes (2)

  • Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function

    Infants receive an MRI at 3 months of age

  • Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function

    Infants receive an MRI scan at less than 2 weeks of age

Secondary Outcomes (1)

  • Nutritional analysis of mothers diet using a food frequency questionnaire

    Mothers fill out questionnaire at three months after enrollment into the study

Other Outcomes (1)

  • Mullen Early scales of Learning (MSEL) test

    This test is conducted with the infants at 3 months of age prior to the month MRI scan.

Study Arms (1)

Infant Group 1

This group consist of healthy, full-term babies whose mothers have no known medical conditions or complications during pregnancy.

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The participants are recruited from two major hospitals at the bedside soon after normal delivery.

You may qualify if:

  • full-term babies whose mothers have no known medical conditions or complications during pregnancy.

You may not qualify if:

  • preterm babies
  • babies whose mothers have significant medical conditions and/or significant complications during pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waltham Imaging Center: Boston Childrens Hospital

Waltham, Massachusetts, 02453, United States

Location

Related Publications (3)

  • Zollei L, Iglesias JE, Ou Y, Grant PE, Fischl B. Infant FreeSurfer: An automated segmentation and surface extraction pipeline for T1-weighted neuroimaging data of infants 0-2 years. Neuroimage. 2020 Sep;218:116946. doi: 10.1016/j.neuroimage.2020.116946. Epub 2020 May 20.

    PMID: 32442637DERIVED

  • Karmacharya S, Gagoski B, Ning L, Vyas R, Cheng HH, Soul J, Newberger JW, Shenton ME, Rathi Y, Grant PE. Advanced diffusion imaging for assessing normal white matter development in neonates and characterizing aberrant development in congenital heart disease. Neuroimage Clin. 2018 May 1;19:360-373. doi: 10.1016/j.nicl.2018.04.032. eCollection 2018.

    PMID: 30013919DERIVED

  • Ferradal SL, Gagoski B, Jaimes C, Yi F, Carruthers C, Vu C, Litt JS, Larsen R, Sutton B, Grant PE, Zollei L. System-Specific Patterns of Thalamocortical Connectivity in Early Brain Development as Revealed by Structural and Functional MRI. Cereb Cortex. 2019 Mar 1;29(3):1218-1229. doi: 10.1093/cercor/bhy028.

    PMID: 29425270DERIVED

Study Officials

  • P Ellen Grant, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 10, 2014

Study Start

March 1, 2014

Primary Completion

May 22, 2017

Study Completion

May 22, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)