Craniosynostosis, SagittalNCT06294626
Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly
An observational study of Craniosynostosis, Sagittal and Scaphocephaly, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 17 months
- Conditions the study is for
- Craniosynostosis, Sagittal, Scaphocephaly, Developmental Delay
- What is being tested?
- Group 1
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 months
- All sexes
- No healthy volunteers
- Child
Study population: 21 cases diagnosed with scaphocephaly aged 2-17 monts were included.
Who may be able to join
- Having been diagnosed with scaphocephaly
- Being between 0-18 months
Who cannot join
- Be over 18 months
- Having a diagnosed disease other than scaphocephaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Altunizade Hospital
Istanbul, Uskudar
About this study
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.
Read the detailed 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.
- Being tested
- Group 1
- Keywords
- scaphocephaly, neuromotor development, alberta infant motor scale, denver II developmental screening test, pediatric rehabilitation
- Medical subject headings
- Craniosynostoses, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
21 cases with scaphocephaly diagnoses were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale.
| Study group | Role | What they receive |
|---|---|---|
| Examination of neuromotor development of cases diagnosed with scaphocephaly | 21 cases with scaphocephaly were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale. Receives: Other: Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniosynostosis, SagittalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilayda Sozeri, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294626
- Sponsor's protocol ID
- ISozeri
- Status last verified
- Sep 2024
- First submitted
- 28 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly
- ClinicalTrials.gov ID
- NCT06294626
- Acronym / sponsor ID
- ISozeri
- Keywords
- scaphocephaly, neuromotor development, alberta infant motor scale, denver II developmental screening test, pediatric rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Examination of neuromotor development of cases diagnosed with scaphocephaly | – | Other: Group 121 cases with scaphocephaly were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale. |
Who may qualify
- Ages
- 2 to 17 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 21 cases diagnosed with scaphocephaly aged 2-17 monts were included.
Key inclusion criteria (2 listed)
- Having been diagnosed with scaphocephaly
- Being between 0-18 months
Key exclusion criteria (2 listed)
- Be over 18 months
- Having a diagnosed disease other than scaphocephaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 121 cases with scaphocephaly diagnoses were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale. | Other | Examination of neuromotor development of cases diagnosed with scaphocephaly |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniosynostosis, Sagittal and Scaphocephaly, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denver-II Developmental Screening Test (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.