N/A
N=386
Clinical Use of a Neonatal MRI System
NICU MRI
Bottom Line
View on ClinicalTrials.gov: NCT03476343 ↗Enrolled (actual)
386
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Adverse Events as Observed During and After Scanning. — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GE OPTIMA MR430s with HDx/GE Electronics (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as Observed During and After Scanning. |
— | — |
| SECONDARY Each Infant's Baseline Measurement for Weight Will be Recorded. |
2.92 | — |
| SECONDARY Each Infant's Anatomy Scanned Will be Obtained. |
357; 1; 2; 13; 1 | — |
| SECONDARY Baseline Measurement for Days Old Will be Recorded. |
20 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Any infant admitted to CCHMC
- Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist
Exclusion Criteria
- Infants too large to fit in the customized NICU MRI system comfortably (generally infants > 6 kg)
- Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Data sourced from ClinicalTrials.gov (NCT03476343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.