Effects of Maternal Body Composition on Offspring Brain Structure and Function

December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
The specific aim of this study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72203
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Full term neonates born from obese or lean mothers enrolled in the Glowing study (IRB#110889)

Description

Inclusion Criteria:

  • the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days

Exclusion Criteria:

  • none specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal weight- Non Maternal obesity
Full-term neonates at 2 weeks of age born to normal weight mothers
Obese- Obese Mothers
Full-term neonates at two weeks of age born of obese mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Structure
Time Frame: Age 2 weeks
We will use high resolution volumetric magnetic resonance imaging (MRI) and Diffusion tensor imaging (DTI) to measure the brain structure of 2 week old infants
Age 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Function
Time Frame: Age 2 weeks
We will use high resolution Resting state functional magnetic resonance imaging (rsfMRI) to measure the brain function of 2 week old infants
Age 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Xiawei Ou, PhD, Arkansas Children's Nutrition Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimated)

April 2, 2013

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 134776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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