Investigation of Anthropometric Properties of Babies With Craniosynostosis

NCT04827524 | Completed

• 1 other identifier: Craniosynostosis
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniosynostoses

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Anthropometric measurement OTHER

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.

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

-Babies diagnosed with craniosynostosis at birth will be included in this study.

You may qualify if:

• Being under 2 years old
• Being diagnosed with non-syndromic craniosynostosis
• Agreeing to participate in the study

You may not qualify if:

• Having a craniomaxillofacial fracture
• Having a history of surgery
• Having a congenital anomaly that affects growth or development

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Yuksek Ihtisas University

Ankara, Çankaya, 06650, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Melek Volkan-Yazici, PhD

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 1, 2021
• Study Start: October 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)