Investigation of Anthropometric Properties of Babies With Craniosynostosis

Craniosynostoses Clinical Trial

Official title:

Investigation of Anthropometric Properties of Babies With Craniosynostosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827524
• Other study ID #: Craniosynostosis
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Yuksek Ihtisas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Craniosynostoses

Intervention

Other:
• Anthropometric measurement
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.

Locations

Country	Name	City	State
Turkey	Yuksek Ihtisas University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas University

Country where clinical trial is conducted

Turkey, 

Outcome

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.