Cerebral PalsyNCT04716530
The Changing Panorama in Risk Factors of Cerebral Palsy
An observational study of Cerebral Palsy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- How many people
- 296 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 20 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in our cerebral palsy database
Who may be able to join
- cerebral palsy patients
Who cannot join
- missing data on the cerebral palsy database
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732
Bilinç Doğruöz Karatekin, +905368308709, bilincdogruoz@hotmail.com
Bilinç Doğruöz Karatekin, MD
About this study
Official title: The Changing Panorama in Risk Factors of Cerebral Palsy: A Single National Tertiary Center Experience
The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database. The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010.Changes in cerebral palsy risk factors will be investigated at 10-year intervals.
Read the detailed description
The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database.
Cerebral palsy subtypes classified according to The Surveillance for Cerebral Palsy in Europe (SCPE) classification into four groups: spastic (unilateral and bilateral), dyskinetic (dystonic and choreoathetoic), ataxic/hypotonic, non-classifiable. Cerebral palsy risk factors will be primarily divided into 4 as preconceptional, antenatal, intrapartum and neonatal risk factors. Then, risk factors in the data will be distributed to the appropriate risk factor group.
The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010. Changes in cerebral palsy risk factors will be investigated at 10-year intervals.
- Conditions
- Cerebral Palsy
- Being tested
- No intervention is associated with the study.
- Keywords
- cerebral palsy, etiology, risk factors, low birth weight, prematurity
- Medical subject headings
- Cerebral Palsy, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is associated with the study.Other
No intervention is associated with the study.
| Study group | Role | What they receive |
|---|---|---|
| born before 2000 | No patient treatment is associated with the study. Receives: Other: No intervention is associated with the study. | |
| born between 2000-2010 | No patient treatment is associated with the study. Receives: Other: No intervention is associated with the study. | |
| born after 2010 | No patient treatment is associated with the study. Receives: Other: No intervention is associated with the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the risk factors of cerebral palsy
Risk factors of cerebral palsy questioned as preconceptional, antenatal, intrapartum and neonatal.
Measured: 1 month
Define the change in the risk factors among age groups
The difference in cerebral palsy risk factors in age groups measured by chi-square statistics (born before 2000/ born between 2000-2010/ born after 2010)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start15 Jan 2021
- Primary completion30 Jan 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716530
- Sponsor's protocol ID
- Istanbul MU CP
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changing Panorama in Risk Factors of Cerebral Palsy: A Single National Tertiary Center Experience
- ClinicalTrials.gov ID
- NCT04716530
- Acronym / sponsor ID
- Istanbul MU CP
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, etiology, risk factors, low birth weight, prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 20 Jan 2021 (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 will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database. The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010.Changes in cerebral palsy risk factors will be investigated at 10-year intervals.
Detailed description
The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database.
Cerebral palsy subtypes classified according to The Surveillance for Cerebral Palsy in Europe (SCPE) classification into four groups: spastic (unilateral and bilateral), dyskinetic (dystonic and choreoathetoic), ataxic/hypotonic, non-classifiable. Cerebral palsy risk factors will be primarily divided into 4 as preconceptional, antenatal, intrapartum and neonatal risk factors. Then, risk factors in the data will be distributed to the appropriate risk factor group.
The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010. Changes in cerebral palsy risk factors will be investigated at 10-year intervals.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| born before 2000 | – | Other: No intervention is associated with the study.No patient treatment is associated with the study. |
| born between 2000-2010 | – | Other: No intervention is associated with the study.No patient treatment is associated with the study. |
| born after 2010 | – | Other: No intervention is associated with the study.No patient treatment is associated with the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in our cerebral palsy database
Key inclusion criteria (1 listed)
- cerebral palsy patients
Key exclusion criteria (1 listed)
- missing data on the cerebral palsy database
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 |
|---|---|---|
| No intervention is associated with the study.No intervention is associated with the study. | Other | born after 2010, born before 2000, born between 2000-2010 |
Primary outcome
Define the risk factors of cerebral palsy
Time frame: 1 month
Risk factors of cerebral palsy questioned as preconceptional, antenatal, intrapartum and neonatal.
Define the change in the risk factors among age groups
Time frame: 1 month
The difference in cerebral palsy risk factors in age groups measured by chi-square statistics (born before 2000/ born between 2000-2010/ born after 2010)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- 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.
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, Turkey (Türkiye)
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 Cerebral Palsy, run by Istanbul Medeniyet University 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 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the risk factors of cerebral palsy (time frame: 1 month). 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 20 Jan 2021.