Clinical trial NCT06813586: Observational Study for the Epidemiology of Cerebral Palsy in Italy
Official title: DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Database
Hospital-based registry
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: Fondazione Pierfranco e Luisa Mariani
name: Fondazione FightTheStroke
name: Istituto Superiore di Sanità
name: IRCCS Eugenio Medea
name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
First posted: 2025-02-07
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is expected to include at least 300 pediatric patients with cerebral palsy (CP) in accordance with the inclusion and exclusion criteria outlined by the SCPE Collaborative Group (2000).

Brief 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 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;

Primary outcomes:
measure: Participants demographic data
timeFrame: Baseline
measure: Cerebral palsy (CP) classification
timeFrame: Baseline
measure: Anamnestic data related to the etiopathogenesis of the disorder
timeFrame: Baseline
measure: Level of Gross Motor Function Classification System (GMFCS)
timeFrame: Baseline
measure: Level of Manual Ability Classification System (MACS)
timeFrame: Baseline
measure: Level of Bimanual Fine Motor Function (BFMF)
timeFrame: Baseline
measure: Level of Visual Function Classification System (VFCS)
timeFrame: Baseline
measure: Level of Communication Function Classification System (CFCS)
timeFrame: Baseline
measure: Level of Viking Speech Scale (VSS)
timeFrame: Baseline
measure: Level of Eating and Drinking Classification System (EDACS)
timeFrame: Baseline
measure: Neuroradiological classification according to the classification promoted by SCPE (MRICS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Associazione La Nostra Famiglia - IRCCS Eugenio Medea
state: Apulia
city: Milano
country: Italy
facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
state: Lombardy
city: Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Tuscany
Study officials:
References:
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