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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058225
• Other study ID #: 84421489-1
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: June 21, 2017
• Start date: March 1, 2014
• Est. completion date: May 22, 2017

Study information

• Verified date: June 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development

Locations

Country	Name	City	State
United States	Waltham Imaging Center: Boston Childrens Hospital	Waltham	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function		Infants receive an MRI at 3 months of age
Primary	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	Nutritional analysis of mothers diet using a food frequency questionnaire		Mothers fill out questionnaire at three months after enrollment into the study