Clinical trial NCT04827524: Investigation of Anthropometric Properties of Babies With Craniosynostosis
Official title: Investigation of Anthropometric Properties of Babies With Craniosynostosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniosynostoses
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Babies diagnosed with craniosynostosis at birth will be included in this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3 dimensional anthropometric analysis of the cranium
timeFrame: Change from baseline anthropometric measure at 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas University
state: Çankaya
Study officials:
affiliation: Yuksek Ihtisas University
name: Melek Volkan-Yazici, PhD
role: PRINCIPAL_INVESTIGATOR
References: