N/A
Completed N=386
Clinical Use of a Neonatal MRI System
NICU MRI
Source: ClinicalTrials.gov NCT03476343 ↗
Enrolled (actual)
386
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Adverse Events as Observed During and After Scanning. — 0 Participants
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.
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 | — |
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. Informational only — not medical advice.