DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of cerebral palsy (CP) confirmed clinically in accordance with recent international guidelines (SCPE Guidelines, 2019);

• Age between 4 and 18 years.

Locations
Other Locations
Italy
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
RECRUITING
Brindisi
IRCCS Fondazione Stella Maris
RECRUITING
Calambrone
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
RECRUITING
Milan
Contact Information
Primary
Giuseppina Sgandurra MD, PhD
giuseppina.sgandurra@fsm.unipi.it
050886284
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 300
Treatments
Children with CP
Children with diagnosed CP age: 4-18 years old
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione FightTheStroke, Istituto Superiore di Sanità, IRCCS Eugenio Medea, Fondazione Pierfranco e Luisa Mariani, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Leads: IRCCS Fondazione Stella Maris

This content was sourced from clinicaltrials.gov