NCT01684527

Brief Summary

The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. This may lead in turn to disturbed lung function. Our aim is to determine the presence and phenotype of immature myeloid cells present in respiratory secretions of children with RSV bronchiolitis as compared to non-RSV bronchiolitis and healthy controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

September 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

September 5, 2012

Last Update Submit

September 10, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Immature Myeloid Cells in Respiratory Secretions

    Respiratory secretions obtained from child presenting with bronchiolitis will be examined for the presence of immature myeloid cells

    Participants will be followed for the duration of hospital stay, an expected average of one week

Study Arms (2)

Children Suffering From Bronchiolitis

Respiratory secretions obtained from children suffering from Bronchiolitis

Other: Respiratory secretions obtained

Healthy Children

Respiratory secretions obtained from children with no respiratory infection

Other: Respiratory secretions obtained

Interventions

Children Suffering From BronchiolitisHealthy Children

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children presenting in our pediatric department suffering from bronchiolitis

You may qualify if:

  • Bronchiolitis

You may not qualify if:

  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 13, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations