N/A
N=657
Clinical Use of a New Neonatal MRI System
Magnetic Resonance Imaging
Bottom Line
View on ClinicalTrials.gov: NCT01801865 ↗Enrolled (actual)
657
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Adverse Events as Observed During and After Scanning. — 4 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
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as Observed During and After Scanning. |
4 | — |
| SECONDARY Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg. |
615 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants heavier than 6 kg)
- Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Data sourced from ClinicalTrials.gov (NCT01801865). 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.