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

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.

Study Overview

• Status: Terminated
• Conditions: Children
• Intervention / Treatment: Procedure: Pre-consultation CRP

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 Type: Interventional
• Enrollment (Actual): 401
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children older than 6 years with other conditions

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-consultation CRP; 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; Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)
No Intervention: CRP requested; No intervention, the consultation with children as normal, the CRP is used at doctors request.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NORCE Norwegian Research Centre AS
• Collaborators: Haukeland University Hospital
• Investigators: Study Director: Steinar Hunskår, Prof. dr.med, NORCE Norwegian Research Centre AS

Publications and helpful links

General Publications

• Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.
• Brent AJ, Lakhanpaul M, Thompson M, Collier J, Ray S, Ninis N, Levin M, MacFaul R. Risk score to stratify children with suspected serious bacterial infection: observational cohort study. Arch Dis Child. 2011 Apr;96(4):361-7. doi: 10.1136/adc.2010.183111. Epub 2011 Jan 24.
• Nordlie AL, Andersen BM. [Changes in antibiotic consumption among day-care children in Oslo]. Tidsskr Nor Laegeforen. 2007 Nov 15;127(22):2924-6. Norwegian.
• Rebnord IK, Sandvik H, Hunskaar S. Use of laboratory tests in out-of-hours services in Norway. Scand J Prim Health Care. 2012 Jun;30(2):76-80. doi: 10.3109/02813432.2012.684208.
• Magnus MC, Vestrheim DF, Nystad W, Haberg SE, Stigum H, London SJ, Bergsaker MA, Caugant DA, Aaberge IS, Nafstad P. Decline in early childhood respiratory tract infections in the Norwegian mother and child cohort study after introduction of pneumococcal conjugate vaccination. Pediatr Infect Dis J. 2012 Sep;31(9):951-5. doi: 10.1097/INF.0b013e31825d2f76.
• Rebnord IK, Sandvik H, Mjelle AB, Hunskaar S. Factors predicting antibiotic prescription and referral to hospital for children with respiratory symptoms: secondary analysis of a randomised controlled study at out-of-hours services in primary care. BMJ Open. 2017 Jan 17;7(1):e012992. doi: 10.1136/bmjopen-2016-012992.
• Rebnord IK, Sandvik H, Mjelle AB, Hunskaar S. Out-of-hours antibiotic prescription after screening with C reactive protein: a randomised controlled study. BMJ Open. 2016 May 12;6(5):e011231. doi: 10.1136/bmjopen-2016-011231. Erratum In: BMJ Open. 2016 Sep 09;6(9):e011231corr1.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Primary Health Care; Anti-Bacterial Agents; C-reactive Protein; Drug Prescriptions; After-Hours Care; Child Welfare
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory
• Other Study ID Numbers: NKLM 2012/1471 RV