Clinical Use of a New Neonatal MRI System
1 other identifier
interventional
657
1 country
1
Brief Summary
The purpose of the present study is to make medically indicated state of the art/high end magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
October 27, 2020
CompletedOctober 27, 2020
October 1, 2020
5.7 years
July 25, 2012
September 2, 2020
October 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events as Observed During and After Scanning.
Any observed physical changes either related or not related to the MRI was recorded during and after scanning.
Day 1
Secondary Outcomes (1)
Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.
Day 1
Study Arms (1)
MRI for Neonates
EXPERIMENTALAll participants will receive an MRI in the NICU scanner in the GE OPTIMA 1.5T MRI at CCHMC.
Interventions
Eligibility Criteria
You may qualify if:
- Any infant admitted to the NICU at CCHMC
- Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
- Able to maintain body temperature for at least 90 minutes without the aid of an incubator or radiant warmer int he opinion of the attending neonatologist
- Parental/LAR permission obtained
You may not qualify if:
- Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 kg)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Results Point of Contact
- Title
- Dr. Beth Kline-Fath
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Beth M Kline-Fath, MD
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2012
First Posted
March 1, 2013
Study Start
April 1, 2012
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
October 27, 2020
Results First Posted
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share