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Completed

NCT Number: NCT02058225

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

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.

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Key information

Conditions

Infant Development

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Waltham Imaging Center: Boston Childrens Hospital

Waltham, Massachusetts, 02453, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Infants receive an MRI at 3 months of age

  2. 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

Secondary outcomes

  1. Nutritional analysis of mothers diet using a food frequency questionnaire

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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2014
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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