NCT02676960

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

6.6 years

First QC Date

January 18, 2016

Last Update Submit

October 15, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of participants that can perform an MRI exam without sedation

    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)

Interventions

MRI without sedationOTHER

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Term born
  • Mother is 18 years or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Xiawei Ou, Ph.D

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

February 9, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(1)