Observational Study for the Epidemiology of Cerebral Palsy in Italy (DataNetCP)

February 3, 2025 updated by: Giuseppina Sgandurra, IRCCS Fondazione Stella Maris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Apulia
      • Brindisi, Apulia, Italy, 72100
        • Recruiting
        • Associazione La Nostra Famiglia - IRCCS Eugenio Medea
        • Contact:
        • Contact:
          • Antonio Trabacca
    • Lombardy
      • Milano, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
        • Contact:
        • Contact:
          • Emanuela Pagliano
    • Tuscany
      • Calambrone, Tuscany, Italy, 56128
        • Recruiting
        • IRCCS Fondazione Stella Maris
        • Contact:
        • Contact:
          • Giuseppina Sgandurra MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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).

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with CP
Children with diagnosed CP age: 4-18 years old
Other: hospital-based registry

The clinical data collected for each patient will reflect comprehensive multiprofessional clinical insights necessary for diagnostic definition and typically obtained during diagnostic evaluation and/or monitoring visits. In addition to these, instrumental data commonly acquired in clinical practice, such as neuroradiological and electrophysiological information, will also be collected.

For each enrolled subject, a checklist (CRF) will be completed to gather study-related data. These data will be entered into a specific database constructed on the REDCap platform and managed in an anonymized form. Subject enrollment will be conducted progressively.

This data collection will enable monitoring of study progress, including the number of enrolled subjects, completed assessments, and study adherence. Every three months, monitoring will be performed to assess study progress and the achievement of enrollment targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants demographic data
Time Frame: Baseline
Age, gender, birth date, place of birth, nationality, address (country)
Baseline
Cerebral palsy (CP) classification
Time Frame: Baseline

Classification of CP according to the European Surveillance Group (SCPE Guidelines, 2019):

Spastic CP (bilateral or unilateral forms); Dyskinetic CP (dystonic form or choreoathetotic form); Ataxic CP.
Baseline
Anamnestic data related to the etiopathogenesis of the disorder
Time Frame: Baseline
This refers to the medical history and background information that help in understanding the cause and development of a disorder i.e. visual and auditory impairments, birth weight, cognitive level, epilepsy, Apgar score and comorbidities.
Baseline
Level of Gross Motor Function Classification System (GMFCS)
Time Frame: Baseline
The Gross Motor Function Classification System (GMFCS), is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility (Rosenbaum et al., 2008).
Baseline
Level of Manual Ability Classification System (MACS)
Time Frame: Baseline
Manual Ability Classification System (MACS) classifies the child's ability from 4 to 18 years old to handle objects in daily activities on one of 5 levels (level I: greater ability, level V: less ability). MACS level I (able to handle objects easily and successfully), level II (able to handle most objects but with somewhat reduced quality and/or speed of achievement so that alternate ways of performance might be used), level III (handles objects with difficulty; needs help to prepare and/or modify activities), level IV (needs continuous support, handles a limited selection of objects), level V (does not handle objects, needs total assistance) (Eliasson et al., 2006).
Baseline
Level of Bimanual Fine Motor Function (BFMF)
Time Frame: Baseline
Bimanual Fine Motor Function (BFMF) classifies fine motor function according to the child's best ability (capacity) to grasp, hold and manipulate objects for each hand separately. BFMF can be used in children from 3-18 years of age (Elvrum et al., 2016).
Baseline
Level of Visual Function Classification System (VFCS)
Time Frame: Baseline
The Visual Function Classification System (VFCS) is a tool used to classify the level of visual function in individuals with disabilities, particularly in the context of cerebral palsy. It is divided into five levels, each describing the degree of visual ability and the impact on daily activities (Baranello et al., 2020).
Baseline
Level of Communication Function Classification System (CFCS)
Time Frame: Baseline
The Communication Function Classification System (CFCS) is a classification tool used to assess and categorize the communication abilities of individuals with cerebral palsy or similar disabilities. It is divided into five levels, each describing the individual's ability to communicate in different environments with both familiar and unfamiliar partners.
Baseline
Level of Viking Speech Scale (VSS)
Time Frame: Baseline
The Viking Speech Scale (VSS) is a classification system designed to assess and categorize the speech abilities of individuals with cerebral palsy or other neurological conditions that affect communication. It focuses on the clarity and intelligibility of speech, as well as the individual's ability to communicate effectively with others. The scale is divided into four levels (Pennington et al., 2013).
Baseline
Level of Eating and Drinking Classification System (EDACS)
Time Frame: Baseline
The Eating and Drinking Classification System (EDACS) is a tool used to classify the eating and drinking abilities of individuals with disabilities, particularly in the context of cerebral palsy. It categorizes individuals into different levels based on their ability to safely and efficiently eat and drink, with a focus on both the safety and efficiency of these activities. The system is divided into five levels (Sellers et al., 2014).
Baseline
Neuroradiological classification according to the classification promoted by SCPE (MRICS)
Time Frame: Baseline

Magnetic Resonance Imaging Classification System is used in the context of neuroradiological assessment in cerebral palsy.

A. Maldevelopments A.1. Disorders of cortical formation (proliferation and/or migration and/or organization A.2. Other maldevelopments (examples: holoprosencephaly Dandy-Walker malformation, corpus callosum agenesis, cerebellar hypoplasia) B. Predominant white matter injury B.1. PVL (mild/severe) B.2. Sequelae of IVH or periventricular haemorrhagic infarction B.3. Combination of PVL and IVH sequelae C. Predominant grey matter injury C.1. Basal ganglia/thalamus lesions (mild/moderate/severe) C.2. Cortico-subcortical lesions only (watershed lesions in parasagittal distribution/multicystic encephalomalacia) not covered under C3 C.3. Arterial infarctions (middle cerebral artery/other) D. Miscellaneous (examples: cerebellar atrophy, cerebral atrophy, delayed myelination, ventriculomegaly not covered under B, haemorrhage not covered under B, brainstem lesions, calcific
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Fondazione Stella Maris

Collaborators

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Istituto Superiore di Sanità
IRCCS Eugenio Medea
Fondazione Pierfranco e Luisa Mariani
Fondazione FightTheStroke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DataNetCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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