Multicenter, prospective pediatric craniectomy and cranioplasty registry of the European Society for Pediatric Neurosurgery (ESPN)

• Conditions: S06; I63; Intracranial injury; Cerebral infarction

• Registration Number: DRKS00027284
• Lead Sponsor: European Society for Pediatric Neurosurgery (ESPN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Any type of underlying cerebral insult; Informed consent obtained; Ability to provide follow-up of at least 24 months after cranioplasty

Exclusion Criteria

Cranioplasty for conditions other than DC (e.g. congenital skull defects)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is the assessment of complication rate, functional outcome and quality of life in children after decompressive craniectomy and cranioplasty in a large cohort. This aim is achieved by means of a structured, systematic recording of patient variables as well as parameters of the disease, therapy and the course of the disease at predefined time points (30 days after decompression craniectomy, 30 days after cranioplasty and 12 and 24 months after cranioplasty). Most items are based on the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements. The following objective scores are used: Pediatric Glasgow Coma Scale (GCS) and Pediatric Risk of Mortality Score (PRISM) as surrogate markers for injury severity, King’s Outcome Scale for Childhood Head Injury (KOSCHI) and KIDSCREEN-10 to measure health-related quality of life and functional outcome as well as the Oulo Resorption Score to measure the extent of autologous bone flap resorption after cranioplasty.

Secondary Outcome Measures

Name	Time	Method
The secondary objective is the comparison of treatment strategies and the identification of predictors for optimal results of decompressive craniectomy and cranioplasty by means of a structured, systematic recording of patient variables as well as parameters of the disease, therapy and the course of the disease at predefined time points (30 days after decompressive craniectomy, 30 days after cranioplasty and 12 and 24 months after cranioplasty).