Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation

December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI) instrument on children aged 6 months up to 5 year old children. This procedure is usually done with sedation but the study will see if it can be done without sedation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

MRI examination of term infants without sedation at a later age (than newborn) can be feasible.

Study Type

Observational

Enrollment (Estimated)

45

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, 72202
        • 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

6 months to 5 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Up to 15 healthy term infants age ~6 months, up to 15 healthy term infants age ~1 year and another up to 15 healthy toddlers at age 2 years, up to 15 healthy children age 3 to 5 years.

Description

Inclusion Criteria:

  • Term born
  • Mother is 18 years or older

Exclusion Criteria:

  • Any previous or current neurological illness or other serious medical conditions
  • Any conditions deemed by the investigators that are not suited for a MRI scan.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that can perform an MRI exam without sedation
Time Frame: From the time of the start of the MRI until the end of the MRI exam (~2 hours)
Perform MRI exam without sedation at a later age than newborn
From the time of the start of the MRI until the end of the MRI exam (~2 hours)

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, Ph.D, 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

January 1, 2016

Primary Completion (Actual)

August 1, 2022

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimated)

February 9, 2016

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 204890

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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