Down SyndromeNCT07260136
Cervical Spine Abnormalities in Down Syndrome
An observational study of Down Syndrome and Cervical Spine Instability in Down Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to determine the prevalence,clinical presentations and radiographic cervical spine abnormalities associated Down syndrome in children at sohag university hospital Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Down Syndrome, Cervical Spine Instability in Down Syndrome
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Oct 2025to 30 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Aims to study the prevalence, clinical presentationsand radiographic cervical spine abnormalities associated with Down syndrome in children at sohag university hospital
Who may be able to join
- All patients attending to pediatric inpatient and outpatient clinics aged from 2y up to 18 y
Who cannot join
- children with other clinical syndromes Children with other neurological disorders (eg. Cerebral palsy , myopathy, neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Cervical Spine Abnormalities Associated With Down Syndrome in Children at Sohag University
The study aims to determine the prevalence,clinical presentations and radiographic cervical spine abnormalities associated Down syndrome in children at sohag university hospital
- Keywords
- Cervical abnormalities associated with Down syndrome
- Medical subject headings
- Down Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence, clinical presentations and radiographic cervical spine abnormalities associated with Down syndrome through study completion an average of 1 year .
Measured: Asses the perivlance of cervical spine abnormalities in patient with Down syndrome of patients aged from 2 years up to 18 years ,using measure tool atlanoaxial instability in ct neck (ADI>3ml)and other mutliple measures ex(weight,height,eg.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start23 Oct 2025
- Primary completion23 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EsraaAMahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260136
- Sponsor's protocol ID
- Soh-Med-25-7_17MS
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cervical Spine Abnormalities Associated With Down Syndrome in Children at Sohag University
- ClinicalTrials.gov ID
- NCT07260136
- Acronym / sponsor ID
- Soh-Med-25-7_17MS
- Keywords
- Cervical abnormalities associated with Down syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
The study aims to determine the prevalence,clinical presentations and radiographic cervical spine abnormalities associated Down syndrome in children at sohag university hospital
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Aims to study the prevalence, clinical presentationsand radiographic cervical spine abnormalities associated with Down syndrome in children at sohag university hospital
Key inclusion criteria (1 listed)
- All patients attending to pediatric inpatient and outpatient clinics aged from 2y up to 18 y
Key exclusion criteria (1 listed)
- children with other clinical syndromes Children with other neurological disorders (eg. Cerebral palsy , myopathy, neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence, clinical presentations and radiographic cervical spine abnormalities associated with Down syndrome through study completion an average of 1 year .
Time frame: Asses the perivlance of cervical spine abnormalities in patient with Down syndrome of patients aged from 2 years up to 18 years ,using measure tool atlanoaxial instability in ct neck (ADI>3ml)and other mutliple measures ex(weight,height,eg.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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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 Down Syndrome and Cervical Spine Instability in Down Syndrome, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Determine the prevalence, clinical presentations and radiographic cervical spine abnormalities associated with Down syndrome through study completion an average of 1 year . (time frame: Asses the perivlance of cervical spine abnormalities in patient with Down syndrome of patients aged from 2 years up to 18 years ,using measure tool atlanoaxial instability in ct neck (ADI>3ml)and other mutliple measures ex(weight,height,eg.)). 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 3 Dec 2025.