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

Primary Purpose

Children

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-consultation CRP
Sponsored by
NORCE Norwegian Research Centre AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Children focused on measuring C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Children older than 6 years with other conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Pre-consultation CRP

    CRP requested

    Arm Description

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

    No intervention, the consultation with children as normal, the CRP is used at doctors request.

    Outcomes

    Primary Outcome Measures

    Antibiotic prescription rate
    Number of participants prescribed antibiotics

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 25, 2015
    Last Updated
    December 2, 2015
    Sponsor
    NORCE Norwegian Research Centre AS
    Collaborators
    Haukeland University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02496559
    Brief Title
    Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
    Official Title
    Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    Lower prevalence than expected and the inclusion was difficult.
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NORCE Norwegian Research Centre AS
    Collaborators
    Haukeland University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Children
    Keywords
    C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    401 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-consultation CRP
    Arm Type
    Active Comparator
    Arm Description
    Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation
    Arm Title
    CRP requested
    Arm Type
    No Intervention
    Arm Description
    No intervention, the consultation with children as normal, the CRP is used at doctors request.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pre-consultation CRP
    Intervention Description
    Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)
    Primary Outcome Measure Information:
    Title
    Antibiotic prescription rate
    Description
    Number of participants prescribed antibiotics
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Hospitalization rate
    Description
    Number of participants referred to hospital
    Time Frame
    24 hours
    Title
    Rate of side-effects of antibiotics
    Description
    Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service
    Time Frame
    7 days
    Title
    Duration of illness
    Description
    Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children 0-6 years with fever and/or respiratory symptoms Exclusion Criteria: Children older than 6 years with other conditions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steinar Hunskår, Prof. dr.med
    Organizational Affiliation
    NORCE Norwegian Research Centre AS
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21266341
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21653621
    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.
    Results Reference
    background
    PubMed Identifier
    18026237
    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.
    Results Reference
    background
    PubMed Identifier
    22643151
    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.
    Results Reference
    result
    PubMed Identifier
    22627867
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28096254
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    27173814
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://uni.no/en/uni-health/national-centre-for-emergency-primary-health-care/diagnostic-equipment-at-norwegian-out-of-hours-services/
    Description
    Project web page

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

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