Co-infections in Children Hospitalised for Bronchiolitis
This study is not yet open for participant recruitment.
Verified October 2012 by Princess Amalia Children's Clinic
Sponsor:
Princess Amalia Children's Clinic
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT01714076
First received: October 8, 2012
Last updated: October 24, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bronchiolitis |
Other: cohort isolation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation |
Further study details as provided by Princess Amalia Children's Clinic:
Primary Outcome Measures:
- co-infection [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: Yes ]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
Secondary Outcome Measures:
- clinical severity [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation
Biospecimen Retention: Samples Without DNA
sputum tested for viral agents by PCR-techniques
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Other: cohort isolation
all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis
|
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.
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
children < 2 years admitted for bronchiolitis
Criteria
Inclusion Criteria:
- younger than 2 years admitted for bronchiolitis
Exclusion Criteria:
- chronic lung disease congenital heart defect down syndrome
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714076
Locations
| Netherlands | |
| Isala Klinieken | Not yet recruiting |
| Zwolle, Overijssel, Netherlands, 8000 GK | |
| Contact: Jolita Bekhof, MD ++31384245050 j.bekhof@isala.nl | |
| Principal Investigator: Jolita Bekhof, MD | |
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
| Principal Investigator: | Jolita Bekhof, MD | Isala Klinieken |
More Information
No publications provided
| Responsible Party: | Jolita Bekhof, MD, Princess Amalia Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT01714076 History of Changes |
| Other Study ID Numbers: | JB-3 |
| Study First Received: | October 8, 2012 |
| Last Updated: | October 24, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013