Swiss Cerebral Palsy Registry

Cerebral Palsy Clinical Trial

— Swiss-CP-Reg  

Official title:

Swiss Cerebral Palsy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992871
• Other study ID #: 2017-00873
• Status: Recruiting
• Start date: June 19, 2017
• Est. completion date: January 2071

Study information

• Verified date: December 2022
• Source: University of Bern
• Contact: Claudia E Kuehni, Prof. MD
• Phone: +41 (0)31 684 35 07
• Email: swiss-cp-reg[@]ispm.unibe.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Swiss-CP-Reg is a national patient registry that collects information on diagnosis, symptoms, treatment and follow-up of patients with cerebral palsy (CP) in Switzerland. It was first implemented in 2017 in the paediatric clinics in Basel, Bellinzona, Bern, Geneva, Lausanne, St. Gallen and Zurich. It will be extended to all Swiss clinics and medical practices and adults will be invited to join the register in the coming years. The registry provides data for national and international monitoring and research. It supports research on CP in Switzerland and the exchange of knowledge between clinicians, researchers and therapists, with the goal to improve the treatment of children and adults with CP and optimizing their health and quality of life.

Description:

Background: Cerebral palsy (CP) refers to chronic movement and postural disorders. It results from a non-progressive lesion or brain malformation that occurs during the prenatal, perinatal, or postnatal period (e.g. ischemic lesions of the neonatal brain or genetic predispositions leading to brain malformation). Besides motor dysfunction, persons with CP suffer from a wide variety of comorbidities, such as epilepsy, speech, hearing or vision disorders, cognitive dysfunction, behavioral disorders, and secondary musculoskeletal problems.

CP is the most common cause of physical disability in children in Switzerland and it is important that the investigators gain a better understanding of its prevalence, risk factors, current clinical profile and the needs of those affected and their families.

The cantonal Ethics Committee of Bern approved the Swiss-CP-Reg project (project ID:

2017-00873, observational study, risk category A).

Objectives: The overall objective of the Swiss-CP-Reg is to improve future care and thus well-being of CP individuals. The development of a national registry for the collection of representative, complete and longitudinal data from children, adolescents and adults with CP in Switzerland serves to achieve this goal.

Primary objectives of the Swiss-CP-Reg projects:

1. Establish a representative population-based Swiss cohort of children, adolescents and adults with CP

2. Provide epidemiological data to investigate the incidence, prevalence, risk factors, spectrum of diagnosis, survival rates and mortality

3. Provide a platform for clinical research:

• Answer questions in the following areas: health, health care, education, social aspects and quality of life

• Offer a resource to recruit patients for nested observational and intervention studies

4. Provide a platform for communication:

• Promote the exchange of knowledge between clinics, researchers, therapists and national and cantonal health authorities

• Facilitate international collaborations, in particular with the "Surveillance of Cerebral Palsy of Europe" (SCPE), and benchmarking of used therapeutic approaches with international partners

Inclusion/exclusion criteria: all children, adolescents and adults diagnosed with CP who are born, treated or living in Switzerland. The SCPE decision tree is used for inclusion/exclusion. Patients with pure muscular hypotonia, neurometabolic diseases (e.g. neuronal storage diseases, leukodystrophies) and other progressive neurological diseases (e.g. spinocerebellar ataxias, hereditary spastic paraplegia, Rett syndrome, epileptic encephalopathy) are excluded.

Procedure: After a CP diagnosis of a child, the treating physician informs the family during a consultation in a clinic or practice in writing and orally about the Swiss-CP-Reg. Families who wish to participate sign the consent form and the children are registered in the Swiss-CP-Reg. If families do not wish to participate, only a minimal anonymous data set is recorded.

The following data will be collected:

• Medical data

• Data from questionnaires for patients and families

• Data from links to routine statistics and medical registries

Clinical data (report of new cases and follow-up reports): CP Classification; Perinatal history; Diagnosis information; Possible CP causes; Neuroradiological examinations; Classification of motor skills (mobility, manual ability); Comorbidities, e.g. epilepsy, visual impairment, pain; Development and learning difficulties; Communication and nutrition; Hip and spinal pathologies (e.g. scoliosis); Treatments and therapies e.g. physiotherapy, hip surgery, medication; Socio-economic resources of the family.

Questionnaire data: Personal information; Health-related quality of life; Participation in daily life; Medical care and medication; Communication and dietary problems; Comorbidities; Treatments; Aids; Education and social environment; Family needs

Routine data and linkages: Communities; Federal Statistical Office (e.g. the birth register, cause of death statistics, hospital statistics); SwissNeoNet (register for premature and at-risk children).

Current status: From 2017-2021, the investigators have included 580 persons diagnosed with CP (Status May 31 2021; from birth year 1998)

The Swiss-CP-Reg contact new diagnosed persons with CP at regular intervals, and continuously analyse and publish data and findings.

Funding: Swiss Foundation for the Cerebrally Palsied Child, Anna Mueller Grocholski Foundation, Swiss Academy of Childhood Disability SACD, Hand in Hand Anstalt, Ostschweizer Kinderspital and ACCENTUS Charitable Foundation (Walter Muggli Fund).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: January 2071
• Est. primary completion date: January 2071
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

Inclusion Criteria:

• Who were diagnosed with CP, confirmation of the diagnosis at the age of 5 years is required

• Who are born, treated for CP or living in Switzerland, and

• Who gave informed consent

Exclusion Criteria:

• Pure muscular hypotonia

• Neurometabolic diseases (e.g. neuronal storage diseases, leukodystrophies)

• Other progressive neurological diseases (e.g. spinocerebellar ataxias, hereditary spastic paraplegia, Rett syndrome, epileptic encephalopathy)

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel, UKBB	Basel
Switzerland	Pediatric Institute of Southern Switzerland, Ospedale San Giovanni	Bellinzona
Switzerland	Institute of Social and Preventive Medicine (ISPM), University of Bern	Bern
Switzerland	University Children's Hospital Bern, Inselspital	Bern
Switzerland	University Hospitals of Geneva	Geneva
Switzerland	University Children's hospital Lausane, CHUV	Lausanne
Switzerland	Children's Hospital of Eastern Switzerland	St. Gallen
Switzerland	University Children's Hospital Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Schweizerische Stiftung für das cerebral gelähmte Kind

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal data	Registering patients personal data	At diagnosis (age 0-5 years)
Primary	Change in date of registration	Change in date of last consultation at physician for data collection	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Birth history neonatal care	Maternal birth history	At diagnosis (age 0-5 years)
Primary	Cause of change in vital status	what caused a change in patients vital status	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Neonatal care	Neonatal care	At diagnosis (age 0-5 years)
Primary	Age	Age at diagnosis	At diagnosis (age 0-5 years)
Primary	Change in classification of CP	Change in CP classification according to SCPE decision tree	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in gross motor function	Change in classification of gross motor function	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in fine motor function	Change in classification of fine motor function	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Postneonatal CP	Classification of postneonatal CP	At diagnosis (age 0-5 years)
Primary	Change in associated syndromes	Change in classification of associated syndromes using ICD code	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change of congenital anomalies	Change in classification of congenital anomalies using ICD code	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change of brain malformation	Change in classification of brain malformation using ICD code	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in genetic syndromes	Change in analysis results on genetic mutation	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in neuroimaging	Registration of change in neuro images	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in anthropometrics	Registration of change in anthropometric data	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in sensory difficulties	Registration of change in sensory capability	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in nutrition	Registration of change in feeding habits	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in speech	Change in classification of verbal communication using VSS	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in communication	Change in classification of communication using CFCS	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in comorbidities	Registration of change in comorbidities	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change of hip	Hip surveillance: registration of change in hip-dislocation	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change of scoliosis	Assessing change in scoliosis using Cobb Winkel	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in surgery	Registering changes in surgery history	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in treatments	Registering changes in treatments	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in therapies	Registering changes in therapies	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Changes in medical equipment	Registering changes in use of medical equipment	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in ancillary service	Registering changes in use of ancillary service	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in mobility	Registering changes in mobility	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Change in cognition	Assessing changes in mental ability using tests	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Changes in behavior	Assessing changes in behavior using scales	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Changes in academic info	Registering changes in info on academic education	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Changes in family history	Registering changes in info on health of family members	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Changes in socio economics	Registering changes in info on parents socio-economic background	follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Changes in epilepsy	Registration changes in epilepsy	Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Primary	Questionnaire data	Questionnaires focusing on specific research questions (Perinatal history, health related questions, health behavior, quality of life, participation, needs, concerns)	5-80 years

External Links

•   Website of the registry