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

Safety and feasibility of ultra-high field magnetic resonance imaging in neonates - 7.0 Tesla MRI in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49275
Enrollment
20
Registered
2018-11-12
Start date
2019-02-11
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain injury encephalopathy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)