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NCT01714076 Clinical Trial

Co-infections in Children Hospitalised for Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01714076
Other study ID # JB-3
Secondary ID
Status Completed
Phase N/A
First received October 8, 2012
Last updated October 21, 2015
Start date November 2012
Est. completion date October 2015

Study information
Verified date October 2015
Source Princess Amalia Children's Clinic
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 172
Est. completion date October 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Months
Eligibility Inclusion Criteria:

- younger than 2 years admitted for bronchiolitis

Exclusion Criteria:

- chronic lung disease congenital heart defect down syndrome

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• cohort isolation
all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis

Locations
Country Name City State
Netherlands Isala Klinieken Zwolle Overijssel

Sponsors (1)
Lead Sponsor Collaborator
Princess Amalia Children's Clinic

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary co-infection 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 approximately 2 weeks Yes
Secondary clinical severity clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation approximately 2 weeks No
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