Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years O... | NCT02676960

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

NCT02676960

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Oct 20, 2025Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Healthy

Interventions

MRI without sedation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Feb 4, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2025

Last Update Posted Date

Oct 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Name	Type	Description	Arm Group Labels	Other Names
MRI without sedation	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiawei Ou, Ph.D	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided