Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly

Developmental Delay Clinical Trial

Official title:

Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06294626
• Other study ID #: ISozeri
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Acibadem Atunizade Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.

21 infants diagnosed with scaphocephaly aged 2-17 months were included.

• Is there any delay in the neuromotor development of scaphocephaly cases?

• If delay is observed, in which area is it most common?

Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants.

Description:

Scaphocephaly (sagittal synostosis) is the most common single-suture craniosynostosis. It occurs as a result of premature ossification of the fibrous connective tissue extending between two parietal bones (sagittal suture). Phenotypically, a long and narrow head shape occurs. It occurs in 2-3 per 10,000 live births and is more common in men.

Premature ossification of the sagittal suture can lead to cranial deformity, potentially cranial growth restriction, and resulting increased intracranial pressure. In these cases, increased intracranial pressure and compression of the sagittal sinus cause increased venous pressure, which may cause developmental delays. These delays most commonly include cognitive impairments, language disorders, motor delays, learning disabilities, executive dysfunction, and behavioral problems.

When looking at the literature, it was seen that the studies were mostly on neurocognitive development in cases with craniosynostosis. There are relatively fewer studies focusing on the neuromotor development of these cases.

This study aims to evaluate the neuromotor development of scaphocephaly cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 17 Months

Eligibility

Inclusion Criteria:

• Having been diagnosed with scaphocephaly

• Being between 0-18 months

Exclusion Criteria:

• Be over 18 months

• Having a diagnosed disease other than scaphocephaly

Related Conditions & MeSH terms

• Craniosynostoses
• Craniosynostosis, Sagittal
• Developmental Delay
• Scaphocephaly

Intervention

Other:
• Group 1
21 cases with scaphocephaly diagnoses were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale.

Locations

Country	Name	City	State
Turkey	Acibadem Altunizade Hospital	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem Atunizade Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Denver-II Developmental Screening Test	It's a screening test used in children aged 0-6 years. The test is done in a short time like 5-20 min. The person who will administer the Denver-II test; must be trained and certified. Standardized test materials are used. The test consists of 4 sections and 134 items. There are personal-social, language, fine motor and gross motor sections. The test result is classified as Normal-Abnormal-Suspicious.	baseline
Primary	Alberta Infant Motor Scale	It's used to observe gross motor functions and evaluate the effectiveness of the intervention in typically developing infants between 0-18 months. The duration of the test is 10 min and consists of 58 items. The child's spontaneous movements are evaluated in 4 different positions without touching the child. 1 point is taken for each item that can be done. A table containing the mean and standard deviation for each month is used. The test result is classified as Normal-Abnormal-Suspicious.	baseline