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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02433327
Date of registration: 27/04/2015
Prospective Registration: No
Primary sponsor: Aarhus University Hospital
Public title: Paediatric Early Warning System - A Danish Multi-center Study
Scientific title: Paediatric Early Warning System - A Danish Multi-center Study
Date of first enrolment: January 2014
Target sample size: 8000
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02433327
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Claus S Jensen, PhD
Address: 
Telephone:
Email:
Affiliation:  Aarhus University Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- All children admitted to the participating departments

- All children examined at the acute paediatric assessment unit in Central Denmark
Region.

Exclusion Criteria:

- Children admitted to neonatal wards

- Children admitted to intensive care units

- Children dead upon arrival to hospital

- Children admitted due to social-interaction problems.



Age minimum: N/A
Age maximum: 15 Years
Gender: All
Health Condition(s) or Problem(s) studied
Paediatric Early Warning System
Intervention(s)
Other: PEWS - trigger tool
Other: RM - trigger tool
Primary Outcome(s)
Unplanned transfers to intensive care or transfers from regional hospitals to university hospital owing to clinical deterioration [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week]
Secondary Outcome(s)
Extra Corporal Membran Oxygenation [Time Frame: through study completion an expected average of 2 years]
Paediatric index of mortality score 3 [Time Frame: through study completion an expected average of 2 years]
Length of hospital stay [Time Frame: through study completion an expected average of 2 years]
Invasive ventilation [Time Frame: through study completion an expected average of 2 years]
Length of PICU stay [Time Frame: through study completion an expected average of 2 years]
Continuous Positive Airway Pressure [Time Frame: through study completion an expected average of 2 years]
Use of inotropes [Time Frame: through study completion an expected average of 2 years]
Secondary ID(s)
PEWS
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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