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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02496559
Enrollment
401
Registered
2015-07-14
Start date
2013-01-31
Completion date
2015-07-31
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children

Keywords

C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions

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.

Interventions

PROCEDUREPre-consultation CRP

Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)

Sponsors

Haukeland University Hospital
CollaboratorOTHER
NORCE Norwegian Research Centre AS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Children older than 6 years with other conditions

Design outcomes

Primary

MeasureTime frameDescription
Antibiotic prescription rate24 hoursNumber of participants prescribed antibiotics

Secondary

MeasureTime frameDescription
Duration of illness7 daysNumber of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
Hospitalization rate24 hoursNumber of participants referred to hospital
Rate of side-effects of antibiotics7 daysNumber of participants with side-effects of antibiotics prescribed at Out-of-hours Service

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026