Safety and feasibility of ultra-high field magnetic resonance imaging in neonates

Completed

• Conditions: brain injury; encephalopathy; 10029299; 10010335; 10028920

• Registration Number: NL-OMON49275
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2020-05-19
• Study Completion: 2021-08-24
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Neonates with a clinical indication for MRI in the Wilhelmina Children*s
Hospital i.e. stroke, perinatal asphyxia, premature infants between term
equivalent age (37 weeks or more) and 3 months post-term;

Exclusion Criteria

- Corpus alienum inside or outside the body that cannot be temporarily removed
i.e. ferrometal, pacemakers, cochlear implants, hydrocephalus pump, aneurysm
clips;
- Instable clinical condition e.g. respiratory support / intravenous or
intra-arterial catheters.
- Very irritable or feeding intolerance

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints of this study are safety, based on the measurement of<br /><br>comfort, feeding intolerance, temperature and vital parameters of the infant,<br /><br>specific absorption rate and sound pressure levels, and the feasibility based<br /><br>on quality of the scan i.e. signal to noise ratio, contrast to noise,<br /><br>B0-inhomogenieties. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>