Clinical trial NCT02058225: Developing Advanced MRI Methods for Detecting the Impact of Nutrients on Infant Brain Development
Official title: Developing Advanced MRI Methods for Detecting the Impact of Nutrients on Infant Brain Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Development
Keywords: Infant Nutrition
Magnetic resonance spectroscopy
Infant Brain Development
Diffusion weighted Imaging
Diffusion tensor tractography
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: University of Illinois at Urbana-Champaign
First posted: 2014-02-10
Enrollment: 130
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants are recruited from two major hospitals at the bedside soon after normal delivery.

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.

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.

Primary outcomes:
measure: Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
timeFrame: Infants receive an MRI at 3 months of age
measure: Magnetic Resonance Imaging to measure of brain metabolites, brain structures and brain function
timeFrame: Infants receive an MRI scan at less than 2 weeks of age
Secondary outcomes:
measure: Nutritional analysis of mothers diet using a food frequency questionnaire
timeFrame: Mothers fill out questionnaire at three months after enrollment into the study
Other outcomes:
measure: Mullen Early scales of Learning (MSEL) test
timeFrame: This test is conducted with the infants at 3 months of age prior to the month MRI scan.
Locations:
city: Waltham
country: United States
facility: Waltham Imaging Center: Boston Childrens Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: P Ellen Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.