Observational study on the epidemiology of cerebral palsy in Italy
DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy
This study is trying to create a national registry for children with cerebral palsy in Italy to gather better information and improve their care and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | IRCCS Fondazione Stella Maris Academic / other |
| Locations | 3 sites (Brindisi, Apulia and 2 other locations) |
| Trial ID | NCT06813586 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a national registry for cerebral palsy (CP) in Italy, addressing the lack of standardized guidelines and comprehensive data on this condition. By creating a shared digital platform across multiple clinical centers, the study will facilitate systematic data collection on CP, including both retrospective and prospective information. The registry will focus on children aged 4 to 18 years with a confirmed diagnosis of CP, allowing for better understanding and characterization of the condition. The initiative seeks to improve the quality of care and treatment options for individuals with CP by providing valuable epidemiological insights.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 18 years with a clinically confirmed diagnosis of cerebral palsy.
Not a fit: Patients with progressive neuromotor disorders or neurological conditions defined by isolated hypotonia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cerebral palsy, ultimately enhancing patient care.
How similar studies have performed: While there have been efforts to study cerebral palsy, this initiative is novel in its approach to create a comprehensive national registry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of cerebral palsy (CP) confirmed clinically in accordance with recent international guidelines (SCPE Guidelines, 2019); * Age between 4 and 18 years. Exclusion Criteria: * Progressive neuromotor disorder (defined as a condition involving the loss of previously acquired abilities); * Patients with a neurological condition defined by isolated hypotonia; * Patients with neurological deficits secondary to spinal injury;
Where this trial is running
Brindisi, Apulia and 2 other locations
- Associazione La Nostra Famiglia - IRCCS Eugenio Medea — Brindisi, Apulia, Italy (Recruiting)
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta — Milan, Lombardy, Italy (Recruiting)
- IRCCS Fondazione Stella Maris — Calambrone, Tuscany, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppina Sgandurra MD, PhD
- Email: giuseppina.sgandurra@fsm.unipi.it
- Phone: 050886284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.