Trends in Prevalence and Comorbidities of Children With Cerebral Palsy in Norway

NCT03413566 | Enrolling By Invitation

• 1 other identifier: 197590
• Study Type: observational
• Target: 707,916
• Locations: 0 countries
• Sites: N/A

Brief Summary

Many studies have reported that the prevalence of cerebral palsy (CP) has been relatively stable and is mainly due to events before birth and therefore cannot be prevented. However, these studies were undertaken in populations born towards the end of the last century. There has since been significant improvement in both obstetrical and neonatal intensive care. The main aim is to investigate trends in the prevalence and clinical characteristics of children with CP in Norway born from 1996 to 2010 in order to gain a modern understanding of the panorama of CP in Norway. The investigators suspect that improved methods of obstetrical and neonatal care introduced in Norway during the last 20 years has resulted in a decrease in the prevalence of CP as well as in the proportion of children with severe CP subtypes and comorbidities. The long term aim is to improve the quality of pregnancy care and newborn medicine for children at risk of CP, and to ensure equal diagnostics and treatment of patients with CP, regardless of place of residence in Norway. For this project, the investigators will use data from three national health registers: The Cerebral Palsy Registry of Norway (CPRN), The Medical Birth Registry of Norway and The Norwegian Patient Registry (NPR). The use of data from these high quality health registries provides us with a unique opportunity to study our aims on a population level, as well as per health region/health trust.

Conditions

Cerebral Palsy

Keywords

Trends; Prevalence; Registries/statistics & numerical data; Epidemiology

Outcome Measures

Primary Outcomes (2)

• Prevalence of cerebral palsy

  Assessment of number of children with cerebral palsy per 1000 live births

  Registration at 5 years of age

• Prevalence of cerebral palsy subtypes

  Assessment of cerebral palsy severity according to Surveillance of Cerebral Palsy in Europe classification tree of CP subtypes: spastic unilateral, spastic bilateral, dyskinetic, ataxic and mixed/unspecified, per 1000 live births

  Registration at 5 years of age

Secondary Outcomes (8)

• Gross Motor Function Classification System (GMFCS)

  Registration at 5 years of age

• Epilepsy

  Registration at 5 years of age

• Cognition

  Registration at 5 years of age

• Viking Speech Scale

  Registration at 5 years of age

• Eating and Drinking Ability Classification System (EDACS)

  Registration at 5 years of age

Study Arms (2)

Children with clinical diagnosis of CP

All children residing in Norway with a validated diagnosis of cerebral palsy.

Other: Clinical diagnosis

Children without CP

All children residing in Norway without a diagnosis of cerebral palsy.

Interventions

Clinical diagnosis OTHER

A clinical diagnosis of cerebral palsy given by a pediatrician at a habilitation center in Norway.

Children with clinical diagnosis of CP

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children residing in Norway born from 1996 to 2010 with a diagnosis of cerebral palsy, confirmed by a pediatrician at one of the habilitation centers in the country.

You may qualify if:

• Validated diagnosis of cerebral palsy

You may not qualify if:

• No diagnosis of cerebral palsy

Sponsors & Collaborators

• Sykehuset i Vestfold HF: lead
• Norwegian University of Science and Technology: collaborator
• Norwegian Institute of Public Health: collaborator

Related Publications (2)

• Hollung SJ, Vik T, Wiik R, Bakken IJ, Andersen GL. Completeness and correctness of cerebral palsy diagnoses in two health registers: implications for estimating prevalence. Dev Med Child Neurol. 2017 Apr;59(4):402-406. doi: 10.1111/dmcn.13341. Epub 2016 Nov 29.

  PMID: 27896812 RESULT

• Hollung SJ, Vik T, Lydersen S, Bakken IJ, Andersen GL. Decreasing prevalence and severity of cerebral palsy in Norway among children born 1999 to 2010 concomitant with improvements in perinatal health. Eur J Paediatr Neurol. 2018 Sep;22(5):814-821. doi: 10.1016/j.ejpn.2018.05.001. Epub 2018 May 8.

  PMID: 29779984 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Guro L Andersen, MD, PhD

  Vestfold Hospital Trust/The Cerebral Palsy Registry of Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Leader of the Cerebral Palsy Registry of Norway

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 29, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share