Developing Advanced MRI Methods for Detecting the Impact of Nutrients on Infant Brain Development

June 21, 2017 updated by: Ellen Grant, Boston Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Waltham Imaging Center: Boston Childrens Hospital

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.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Infant Group 1
This group consist of healthy, full-term babies whose mothers have no known medical conditions or complications during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
Time Frame: Infants receive an MRI at 3 months of age
Infants receive an MRI at 3 months of age
Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
Time Frame: Infants receive an MRI scan at less than 2 weeks of age
Infants receive an MRI scan at less than 2 weeks of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Nutritional analysis of mothers diet using a food frequency questionnaire
Time Frame: Mothers fill out questionnaire at three months after enrollment into the study
Mothers fill out questionnaire at three months after enrollment into the study

Other Outcome Measures

Outcome Measure
Time Frame
Mullen Early scales of Learning (MSEL) test
Time Frame: This test is conducted with the infants at 3 months of age prior to the month MRI scan.
This test is conducted with the infants at 3 months of age prior to the month MRI scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: P Ellen Grant, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

May 22, 2017

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (Estimate)

February 10, 2014

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 84421489-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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