Investigation of Anthropometric Properties of Babies With Craniosynostosis

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.

Study Overview

• Status: Completed
• Conditions: Craniosynostoses
• Intervention / Treatment: Other: Anthropometric measurement

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06650
      • Yuksek Ihtisas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Yuksek Ihtisas University
• Investigators: Principal Investigator: Melek Volkan-Yazici, PhD, Yuksek Ihtisas University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Synostosis; Craniosynostoses
• Other Study ID Numbers: Craniosynostosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to ethical reasons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No