An observational study in Craniosynostosis, Sagittal, Scaphocephaly and Developmental Delay, sponsored by Acıbadem Atunizade Hospital. Completed at 1 site in Turkey. Open to participants aged 2 Months to 17 Months. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Acıbadem Atunizade Hospital · Observational
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.
Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants.
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 21 is below the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Acıbadem Atunizade Hospital is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
21 cases diagnosed with scaphocephaly aged 2-17 monts were included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
21 cases with scaphocephaly were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale.
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.
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.
Time frame: baseline
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.
Time frame: baseline
Plan to share: No — Individual participant data will not be made available to other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Acıbadem Atunizade Hospital