Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly

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.

Completed

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Key information

Conditions

Craniosynostosis, Sagittal Bone Diseases Bone Diseases, Developmental Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Developmental Delay Dysostoses Learning Disabilities Mental Disorders Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Scaphocephaly Signs and Symptoms Synostosis

Age range

2 month–17 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem Altunizade Hospital

Istanbul, Uskudar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

Other

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

Primary outcomes

Denver-II Developmental Screening Test

Time frame: baseline

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.
Alberta Infant Motor Scale

Time frame: baseline

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.

Sponsors and collaborators

Lead sponsor

Acıbadem Atunizade Hospital

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Mar 5, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed