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临床试验 NCT04992871 (Swiss-CP-Reg) 针对脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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伯尔尼大学Swiss Cerebral Palsy Registry (Swiss-CP-Reg) 15,000 国际
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT04992871 (Swiss-CP-Reg)是一项针对脑瘫的观察研究试验，目前试验状态为招募中。试验始于2017年6月19日，计划招募15,000名患者。该研究由伯尔尼大学主导，预计于2071年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月13日。
简要概括
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 i...显示更多
详细描述
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, ...显示更多
官方标题
Swiss Cerebral Palsy Registry
疾病
脑瘫出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- Swiss-CP-Reg
- 2017-00873
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Patient population Children, adolescents and adults diagnosed with cerebral palsy who are born, treated or living in Switzerland | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Personal data | Registering patients personal data | At diagnosis (age 0-5 years) |
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)) |
Birth history neonatal care | Maternal birth history | At diagnosis (age 0-5 years) |
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)) |
Neonatal care | Neonatal care | At diagnosis (age 0-5 years) |
Age | Age at diagnosis | At diagnosis (age 0-5 years) |
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)) |
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)) |
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)) |
Postneonatal CP | Classification of postneonatal CP | At diagnosis (age 0-5 years) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
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)) |
Questionnaire data | Questionnaires focusing on specific research questions (Perinatal history, health related questions, health behavior, quality of life, participation, needs, concerns) | 5-80 years |
Change in cognition | Assessing changes in mental ability using tests and school typ | 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)) |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
0 Years
适龄性别
全部
- 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
- 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)
伯尔尼大学178 个活跃的临床试验可供探索- Schweizerische Stiftung für das cerebral gelähmte Kind
- SwissPedNet
研究中心联系人
联系人: Claudia E Kuehni, Prof. MD, +41 31 684 35 07, [email protected]
12 位于 1 个国家/地区的研究中心
Aarau Cantonal Hospital, Aarau, Switzerland
Christina Rüsch, Dr. med, 联系人
招募中
University Children's Hospital Basel, UKBB, Basel, Switzerland
Stephanie Jünemann, Dr. med, 联系人
招募中
Pediatric Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland
Barbara B Goeggel-Simonetti, PD Dr. med, 联系人
招募中
Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
Claudia E Kuehni, Prof. MD, 联系人, +41 31 684 35 07, [email protected]
招募中
University Children's Hospital Bern, Inselspital, Bern, Switzerland
Sebastian Grunt, PD Dr. med, 联系人
招募中
Zentrum für Entwicklungsförderung und pädiatrische Neurorehabilitation, Biel, Switzerland
Chantal Gammenthaler-Zaugg, Dr. med, 联系人
招募中
University Hospitals of Geneva, Geneva, Switzerland
Joel Fluss, PD Dr, 联系人
招募中
University Children's hospital Lausane, CHUV, Lausanne, Switzerland
Christopher Newman, PD Dr, 联系人
招募中
Lucerne Cantonal Hospital, Lucerne, Switzerland
Mareike Schimmel, Dr. med, 联系人
招募中
Children's Hospital of Eastern Switzerland, Sankt Gallen, Switzerland
Steffen Berweck, Prof Dr med, 联系人
招募中
Zentrum für Kinder mit Sinnes- und Körperbeeinträchtigung, Solothurn, Switzerland
Letizia von Laer, Dr. med, 联系人
招募中
University Children's Hospital Zurich, Zurich, Switzerland
Andreas Meyer-Heim, PD Dr. med, 联系人
招募中