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

Completed

• Conditions: Infant Development

• Registration Number: NCT02058225
• Lead Sponsor: Boston Children's Hospital

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.

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 Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-10
• Study Start: 2014-03-01
• Primary Completion: 2017-05-22
• Study Completion: 2017-05-22
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Nutritional analysis of mothers diet using a food frequency questionnaire	Mothers fill out questionnaire at three months after enrollment into the study

Trial Locations

Locations (1)

Waltham Imaging Center: Boston Childrens Hospital; 🇺🇸 Waltham, Massachusetts, United States