Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway

Not Applicable

Terminated

• Conditions: Children
• Interventions: Procedure: Pre-consultation CRP

• Registration Number: NCT02496559
• Lead Sponsor: NORCE Norwegian Research Centre AS

Brief Summary

Viral self-limiting infections in respiratory organs among children are common in primary care. Serious infections have low prevalence and are challenging to distinguish from self-limiting infections.

Prescription of antibiotics in primary care is still high but stable since 2009 in Norway, and 90% of all antibiotics are prescribed in primary care.

C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in primary care, but its role in ruling-out serious infections and the cut-off value for prescribing antibiotics has been discussed a lot.

The aim of this study is to identify if pretesting with CRP of all children 0-6 year with fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of antibiotics and the referral to hospital for children.

Detailed Description

Design: A randomized controlled observational study including children 0-6 year with fever and/or respiratory symptoms at 4 different Out-of-hour Services and at 1 Emergency Children Department Clinic at a hospital (open clinic). The data consist of clinical data and anamnestic information from a nurse at OOH-service collected before the consultation, the doctor's journal and a questionnaire to parents before the consultation and 1 week after the consultation.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-25
• Study Completion: 2015-07
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• Children 0-6 years with fever and/or respiratory symptoms

Exclusion Criteria

• Children older than 6 years with other conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-consultation CRP	Pre-consultation CRP	Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation

Primary Outcome Measures

Name	Time	Method
Antibiotic prescription rate	24 hours	Number of participants prescribed antibiotics

Secondary Outcome Measures

Name	Time	Method
Rate of side-effects of antibiotics	7 days	Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service
Duration of illness	7 days	Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
Hospitalization rate	24 hours	Number of participants referred to hospital