Craniosynostoses Clinical Trial
Official title:
Investigation of Anthropometric Properties of Babies With Craniosynostosis
Verified date | July 2021 |
Source | Yuksek Ihtisas University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Craniosynostosis is a malformation affecting the head and face, in which one or more sutures in the skull are fused prematurely. Premature union of one or more sutures causes changes in the shape of the skull base and dome, resulting in asymmetrical or restricted head and facial enlargement. It has been reported that in craniosynostosis, the bone enlargement is perpendicular to the fused sutures with the counterbalancing expansion. Craniosynostosis usually involves the union of a single cranial suture, but in some cases it has been observed that it may involve more than one suture in the baby's skull. An asymmetrical appearance is observed on the faces of babies, especially an unusual appearance in the form of eyes and skulls. It may present with neurological defects such as hydrocephalus, mental retardation, vision and hearing loss, as well as cosmetic deformities in the skull and facial bones. The general prevalence of craniosynostosis is around 1/2500 births. Generally, in single suture synostoses, there is no clear neurological finding except deformity. In multisuture synostoses there are a wide spectrum of findings such as increased intracranial pressure, hydrocephalus, syringomyelia, Chiari malformation, venous anomalies, ophthalmologic problems, growth retardation and epilepsy. Early diagnosis and treatment provides enough room for the baby's brain to grow and develop. It is thought that by measuring the anthropometric properties of these babies, the course of their development will be examined.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 30, 2021 |
Est. primary completion date | March 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 2 Years |
Eligibility | Inclusion Criteria: - Being under 2 years old - Being diagnosed with non-syndromic craniosynostosis - Agreeing to participate in the study Exclusion Criteria: - Having a craniomaxillofacial fracture - Having a history of surgery - Having a congenital anomaly that affects growth or development |
Country | Name | City | State |
---|---|---|---|
Turkey | Yuksek Ihtisas University | Ankara | Çankaya |
Lead Sponsor | Collaborator |
---|---|
Yuksek Ihtisas University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 dimensional anthropometric analysis of the cranium | The 3 dimensional anthropometric analysis of the subjects cranium wil be measured using the Star Scanner device. | Change from baseline anthropometric measure at 3 months. |
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