A multicentre, randomised intervention study of the Paediatric Early Warning Score: study protocol for a randomised...

Area of Science:

• Pediatric critical care medicine
• Clinical trial methodology
• Health informatics

Background:

• Identifying critical illness in children is challenging due to atypical symptoms.
• Existing Paediatric Early Warning Score (PEWS) models have limitations in clinical practice.
• Low adherence to the Bedside PEWS model has been observed.

Purpose of the Study:

• To compare two PEWS models for identifying acutely and critically ill children.
• To determine if the Central Denmark Region PEWS model is superior to the Bedside PEWS.
• To reduce unplanned transfers to intensive care or between hospitals.

Main Methods:

• A multicentre, randomised, controlled clinical trial involving paediatric and emergency departments.
• Children allocated to either the Central Denmark Region PEWS model or the Bedside PEWS model.
• Primary outcome: unplanned transfer to paediatric intensive care unit or between hospitals.

Main Results:

• The study is designed to include 14,000 children to detect a 30% difference in unplanned transfers.
• A safety interim analysis will be conducted after 7000 patients are included.
• This is the first randomised trial comparing two PEWS models.

Conclusions:

• This trial will provide evidence on the safety and effectiveness of a new PEWS model.
• The findings will contribute to better management of clinical deterioration in hospitalised children.
• Improved PEWS models can enhance early detection and intervention for critically ill children.