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Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy

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ClinicalTrials.gov Identifier: NCT01109589
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : April 23, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

The main objective is to investigate the incidence of Respiratory Tract Infections (RTIs) and antibiotic prescriptions in children and during pregnancy, the different drugs chosen by their doctors according to diagnosis, and compliance by patients. Further to investigate the possible effect of antibiotic use during pregnancy on RTIs and antibiotics and respiratory drug prescriptions in children the first two years after birth.

Specific study objectives:

  • RTIs and antibiotic prescriptions in pre-school children

    • Frequency of diagnoses and antibiotic prescriptions
    • The proportion of broad spectrum antibiotics chosen
  • Prescription patterns and treatment compliance during pregnancy

    • Incidence of diagnoses, compared with not pregnant patients
    • Choice of antibiotics in RTIs
    • Prescription collection from pharmacies
  • Antibiotics and respiratory medication in children aged 0-2 yrs

    • Compare prevalence in children of mothers with frequent RTIs/antibiotic prescriptions during pregnancy and prevalence in children of mothers with few or no consultations during pregnancy
    • Incidence of wheezing and asthma diagnoses and incidence og respiratory prescription drugs when the mother has received antibiotics in pregnancy

Condition or disease
Respiratory Tract Diagnoses (ICPC-2) Prescriptions of Antibiotics by General Practitioners Prescriptions of ATC J01 and R Drugs in Participants

Study Design

Study Type : Observational
Estimated Enrollment : 60000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Respiratory Tract Infections and Prescription Drugs in Children and in Pregnancy - a Study From Norwegian General Practice
Study Start Date : December 2004
Primary Completion Date : December 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Children aged 0-2 yrs
Women aged 15-60 yrs


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Contacts with general practitioner in different parts of Norway. Women aged 15-60 yrs and children 0-2 yrs are selected.
Criteria

Inclusion Criteria:

  • Contact with general practitioner in the time of registration

Exclusion Criteria:

  • Men (except children aged 0-2 yrs)
  • Women in ages 2-14 and above 60 yrs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109589


Locations
Norway
Antibiotic Centre for Primary Care, University of Oslo
Oslo, Norway, 0318
Sponsors and Collaborators
University of Oslo
More Information

Responsible Party: Professor Morten Lindbæk, MD, PhD, Antibiotic Centre for Primary Care, University of Oslo
ClinicalTrials.gov Identifier: NCT01109589     History of Changes
Other Study ID Numbers: ASP-UIO-2010
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: April 2010

Keywords provided by University of Oslo:
antibiotics
prescriptions
pregnancy
children

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases