Clinical trial NCT04992871: Swiss Cerebral Palsy Registry
Official title: Swiss Cerebral Palsy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Schweizerische Stiftung für das cerebral gelähmte Kind
First posted: 2021-08-05
Enrollment: 15000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals living, born, or treated with a diagnosis of cerebral palsy in Switzerland

Brief 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 is currently 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.

Detailed 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 \&#34;Surveillance of Cerebral Palsy of Europe\&#34; (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 Cerebral Foundation, Anna Mueller Grocholski Foundation, Swiss Academy of Childhood Disability SACD, Hand in Hand Anstalt, Ostschweizer Kinderspital and ACCENTUS Charitable Foundation (Walter Muggli Fund).

Eligibility criteria: 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)

Primary outcomes:
measure: Personal data
timeFrame: At diagnosis (age 0-5 years)
measure: Change in date of registration
timeFrame: 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))
measure: Birth history neonatal care
timeFrame: At diagnosis (age 0-5 years)
measure: Cause of change in vital status
timeFrame: 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))
measure: Neonatal care
timeFrame: At diagnosis (age 0-5 years)
measure: Age
timeFrame: At diagnosis (age 0-5 years)
measure: Change in classification of CP
timeFrame: 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))
measure: Change in gross motor function
timeFrame: 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))
measure: Change in fine motor function
timeFrame: 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))
measure: Postneonatal CP
timeFrame: At diagnosis (age 0-5 years)
measure: Change in associated syndromes
timeFrame: 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))
measure: Change of congenital anomalies
timeFrame: 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))
measure: Change of brain malformation
timeFrame: 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))
measure: Change in genetic syndromes
timeFrame: 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))
measure: Change in neuroimaging
timeFrame: 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))
measure: Change in anthropometrics
timeFrame: 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))
measure: Change in sensory difficulties
timeFrame: 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))
measure: Change in nutrition
timeFrame: 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))
measure: Change in speech
timeFrame: 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))
measure: Change in communication
timeFrame: 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))
measure: Change in comorbidities
timeFrame: 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))
measure: Change of hip
timeFrame: 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))
measure: Change of scoliosis
timeFrame: 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))
measure: Change in surgery
timeFrame: 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))
measure: Change in treatments
timeFrame: 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))
measure: Change in therapies
timeFrame: 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))
measure: Changes in medical equipment
timeFrame: 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))
measure: Change in ancillary service
timeFrame: 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))
measure: Change in mobility
timeFrame: 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))
measure: Changes in behavior
timeFrame: 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))
measure: Changes in academic info
timeFrame: 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))
measure: Changes in family history
timeFrame: 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))
measure: Changes in socio economics
timeFrame: 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))
measure: Changes in epilepsy
timeFrame: 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))
measure: Questionnaire data
timeFrame: 5-80 years
measure: Change in cognition
timeFrame: 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))
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel, UKBB
city: Bellinzona
country: Switzerland
facility: Pediatric Institute of Southern Switzerland, Ospedale San Giovanni
city: Bern
country: Switzerland
facility: Institute of Social and Preventive Medicine (ISPM), University of Bern
city: Bern
country: Switzerland
facility: University Children's Hospital Bern, Inselspital
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
city: Lausanne
country: Switzerland
facility: University Children's hospital Lausane, CHUV
city: St. Gallen
country: Switzerland
facility: Children's Hospital of Eastern Switzerland
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: Institute of Social and Preventive Medicine (ISPM), University of Bern
name: Claudia E Kuehni, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belle FN, Hunziker S, Fluss J, Grunt S, Juenemann S, Kuenzle C, Meyer-Heim A, Newman CJ, Ramelli GP, Weber P, Claudia E K, Tscherter A. Cohort profile: the Swiss Cerebral Palsy Registry (Swiss-CP-Reg) cohort study. Swiss Med Wkly. 2022 Feb 21;152:w30139. doi: 10.4414/smw.2022.w30139. eCollection 2022 Feb 14.