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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02496559
• Other study ID #: NKLM 2012/1471 RV
• Status: Terminated
• Phase: N/A
• First received: June 25, 2015
• Last updated: December 2, 2015
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Uni Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 401
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children older than 6 years with other conditions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Children
• Signs and Symptoms, Respiratory

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Uni Research	Haukeland University Hospital

References & Publications (5)

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. — View Citation

Magnus MC, Vestrheim DF, Nystad W, Håberg 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 c — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic prescription rate	Number of participants prescribed antibiotics	24 hours	No
Secondary	Hospitalization rate	Number of participants referred to hospital	24 hours	No
Secondary	Rate of side-effects of antibiotics	Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service	7 days	No
Secondary	Duration of illness	Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.	7 days	No

External Links

•   Project web page