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NCT03476343

Clinical Use of a Neonatal MRI System

Completed NA Results posted Last updated 12 February 2025
What this trial tests

NA trial testing GE OPTIMA MR430s with HDx/GE Electronics in NICU MRI in 386 participants. Completed in 9 September 2022.

Timeline
11 February 2018
Primary endpoint
3 June 2022
9 September 2022

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment386
Start date11 February 2018
Primary completion3 June 2022
Estimated completion9 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Eligibility, any sex, with NICU MRI. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events as Observed During and After Scanning. Primary · Day 1

Any observed physical changes will be recorded during and after scanning

GroupValue95% CI
MRI for Neonates0
Each Infant's Baseline Measurement for Weight Will be Recorded. Secondary · Day 1

These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.

GroupValue95% CI
MRI for Neonates2.920.54 – 4.89
Each Infant's Anatomy Scanned Will be Obtained. Secondary · Day 1

The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system.

GroupValue95% CI
MRI for Neonates357
MRI for Neonates1
MRI for Neonates2
MRI for Neonates13
Baseline Measurement for Days Old Will be Recorded. Secondary · Day 1

These measures will be used in conjunction with the weight at the time of scan to facilitate future design of coils and transport tables for the customized MRI system.

GroupValue95% CI
MRI for Neonates201 – 155

Sponsor's own description

The purpose of the present study is to continue clinical scanning on the NICU MRI with improved administrative processes and procedures, thereby making medically indicated, state of the art/high end MRI exams available to all infants treated at CCHMC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03476343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing