An observational study in Craniosynostoses, sponsored by Yuksek Ihtisas University. Completed at 1 site in Turkey. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by Yuksek Ihtisas University · 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.
Babies diagnosed with craniosynostosis at birth will be included in this study. The patients will be diagnosed using a combination of physical examination, skull radiographs and 3 dimensional computerized tomography scans.A voluntary consent form will be signed by the parents of all subjects indicating that they are willing to participate in the study. Anthropometric measurements of all subjects will be measured with the Star Scanner device.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 30 is below the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Yuksek Ihtisas University is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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-Babies diagnosed with craniosynostosis at birth will be included in this study.
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Exclusion Criteria:
The demographic information and birth histories of the subjects included in the study will be taken first. Anthropometric measurements of all subjects will be measured with the Star Scanner device. The Star Scanner 3 dimensional data collection system is a scanning system that enables the anthropometric head measurements of the baby to be taken in just 2 seconds. The advantages of this device is that it does not emit any harmful beams during evaluation, it does not have any harmful effects on health, and that it is an application that will not disturb babies.
3 dimensional anthropometric analysis of the cranium
The 3 dimensional anthropometric analysis of the subjects cranium wil be measured using the Star Scanner device.
Time frame: Change from baseline anthropometric measure at 3 months.
Plan to share: No — Individual participant data will not be shared due to ethical reasons.
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Ran from Oct 2020 to primary completion in Mar 2021, 5 months.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Yuksek Ihtisas University