NCT01714076

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

October 8, 2012

Last Update Submit

October 21, 2015

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • clinical severity

    approximately 2 weeks

Study Arms (1)

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

Interventions

cohort isolationOTHER

all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis

cohort isolation

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children \< 2 years admitted for bronchiolitis

You may qualify if:

  • younger than 2 years admitted for bronchiolitis

You may not qualify if:

  • chronic lung disease congenital heart defect down syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8000 GK, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum tested for viral agents by PCR-techniques

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Jolita Bekhof, MD

    Isala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 25, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

NL(1)