Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation
October 15, 2025 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
Detailed Description
MRI examination of term infants without sedation at a later age (than newborn) can be feasible.
Study Type
Observational
Enrollment (Actual)
23
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
-
-
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.
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 (Actual)
January 1, 2016
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
August 1, 2022
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 (Actual)
October 20, 2025
Last Update Submitted That Met QC Criteria
October 15, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
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.