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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Children

Intervention / Treatment
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* Procedure: Pre-consultation CRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 0-6 years with fever and/or respiratory symptoms Exclusion Criteria: Children older than 6 years with other conditions

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-consultation CRP<br>Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation | Procedure: Pre-consultation CRP<br>* Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)<br>|
| No Intervention: CRP requested<br>No intervention, the consultation with children as normal, the CRP is used at doctors request. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic prescription rate | Number of participants prescribed antibiotics | 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions