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DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy
BACKGROUND AND RATIONALE Cerebral Palsy (CP) is the leading cause of childhood disability, with an estimated prevalence of 2 to 2.5 per 1,000 births. This complex clinical condition encompasses motor development disorders as well as sensory, communication, cognitive, and emotional impairments. Despite the significant healthcare impact of CP, standardized guidelines for its study and treatment are lacking both nationally and internationally. Existing literature is limited by small sample sizes, inconsistent assessment tools, and insufficient etiopathogenetic and functional characterizations of different CP types. A national registry, which could offer comprehensive epidemiological data, does not currently exist. This project aims to create a shared digital platform across clinical centers throughout Italy (three coordinative centers for northern, central, and southern Italy). This platform will allow systematic, standardized, retrospective, and prospective data collection, including clinical, instrumental, and genetic data (where available) for patients with CP. The study intends to complement ongoing national projects, such as the "Italian Network for Early Detection and Intervention in Developmental Disabilities (INEED)" and the "Italian Network for Cerebral Palsy (Ita-Net-CP)." STUDY OBJECTIVES This study aims to analyze epidemiological data, specifically: * Evaluating the prevalence of various clinical types of CP * Assessing the distribution of functional impairment severity and associated comorbidities. STUDY DESIGN This is a non-profit, multicenter, observational study involving a cohort of CP patients, promoted within the Mariani Foundation Network. The study involves both retrospective and prospective data collection. It will enroll both patients already under care for follow-up and newly diagnosed patients. A sample of at least 300 children and/or adolescents with CP of various etiologies, with 100 participants per clinical center, is targeted. Enrollment will be voluntary, either by invitation from the referring physician, who will explain the importance of the registry, or through project dissemination, allowing parents to request their children's inclusion. Basic registry items can be filled out by parents and, with permission, the primary physician for clinical fields. Parents can opt to be included in the registry to receive information on national clinical studies, approved by ethics committees. Collected essential data includes: * Identification and contact information for patient pseudonymization * Socioeconomic status * CP classification according to the European Surveillance Group * Anamnesis regarding disorder etiology * Neuroradiological classification based on SCPE (MRICS) * Functional impairment level of each child * Significant comorbidities STUDY POPULATION At least 300 pediatric CP patients aged 4-18 years are expected to be recruited. Exclusion criteria only include lack of informed consent. DRUG, MEDICAL DEVICE, NUTRACEUTICAL, BIOLOGICAL SAMPLES, OTHER ELEMENTS This observational study involves systematic, standardized retrospective and prospective data collection of clinical, instrumental, and genetic data (if available). No medical devices, pharmaceuticals, or nutraceuticals will be used. No human biological samples will be collected. STUDY TIMELINE Study duration per patient: aligned with routine clinical visits. No additional evaluations are foreseen. Recruitment duration: 12 months Overall study duration: 36 months SAMPLE SIZE AND DATA ANALYSIS The study aims to recruit at least 300 pediatric CP patients. A control group is not planned.
Age
4 - 18 years
Sex
ALL
Healthy Volunteers
No
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Brindisi, Apulia, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
IRCCS Fondazione Stella Maris
Calambrone, Tuscany, Italy
Start Date
June 1, 2023
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2026
Last Updated
February 7, 2025
300
ESTIMATED participants
hospital-based registry
OTHER
Lead Sponsor
IRCCS Fondazione Stella Maris
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07428928