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

NCT ID: NCT02058225

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2017-05-22

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.

Conditions

Infant Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infant Group 1

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

No interventions assigned to this group

Eligibility Criteria

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.

• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen Grant

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P Ellen Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Waltham Imaging Center: Boston Childrens Hospital

Waltham, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32442637 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30013919 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29425270 (View on PubMed)

Other Identifiers

84421489-1

Identifier Type: -

Identifier Source: org_study_id