- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01714076
Co-infections in Children Hospitalised for Bronchiolitis
October 21, 2015 updated by: Jolita Bekhof, Princess Amalia Children's Clinic
Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation
Observational cohort study in children hospitalized for acute bronchiolitis.
Patients are nursed in cohort isolation.
Aim is to investigate the incidence and clinical impact of co-infections in this group.
Study Overview
Detailed Description
Observational cohort study in children hospitalized for acute bronchiolitis.
Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis.
Aim is to investigate the incidence and clinical impact of co-infections in this group.
Study Type
Observational
Enrollment (Actual)
172
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Overijssel
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Zwolle, Overijssel, Netherlands, 8000 GK
- Isala Klinieken
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
children < 2 years admitted for bronchiolitis
Description
Inclusion Criteria:
- younger than 2 years admitted for bronchiolitis
Exclusion Criteria:
- chronic lung disease congenital heart defect down syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cohort isolation
patients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients
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all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
co-infection
Time Frame: approximately 2 weeks
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co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks
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approximately 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical severity
Time Frame: approximately 2 weeks
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clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation
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approximately 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jolita Bekhof, MD, Isala
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 8, 2012
First Submitted That Met QC Criteria
October 24, 2012
First Posted (Estimate)
October 25, 2012
Study Record Updates
Last Update Posted (Estimate)
October 22, 2015
Last Update Submitted That Met QC Criteria
October 21, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JB-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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