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Black bone MRI in unisutural craniosynostosis patients.

Black bone MRI in unisutural craniosynostosis patients. - BBMRI Cranio

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46249
Enrollment
100
Registered
2018-09-21
Start date
2018-07-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

a medical condition in which some or all of the sutures in the skull of an infant close too early

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - informed consent from the parents - no syndromic diagnosis (i.e. additional congenital anomalies besides the craniosynostosis) - aged between 3 and 12 months - regarding trigonocephaly: moderate and severe presentation for which surgery is considered

Exclusion criteria

Exclusion criteria: - no informed consent from the parents - syndromic diagnosis - older than 12 months of age - mild trigonocephaly

Design outcomes

Primary

MeasureTime frame
Main parameters are the DTI and ASL data and ophthalmologic data from the black bone MRI, and the psychological test data taken at 2, 4, and 6 years of age. The inclusion of patients for black bone MRI stops after 2 years if a sufficient number of patients is included, while the study stops once the last included patient has had its final psychological assessment at 6 years of age.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)