NCT03362125

Brief Summary

Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 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

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

November 15, 2017

Last Update Submit

November 28, 2017

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • Relationship between the duration of oxygen therapy and Wang's score

    Linear regression, to try to model the duration in hours of oxygen therapy according to Wang's score

    through oxygen therapy completion an average of 82 hours

Secondary Outcomes (3)

  • length of hospital stay

    until the end of hospitalization an average of 10 days

  • use of oxygen therapy

    until the end of hospitalization an average of 10 days

  • transfer in intensive care

    until the end of hospitalization an average of 10 days

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants less than 2 years old visiting the emergency department of the University Hospital of Rennes for a first or second episode of bronchiolitis with criteria for hospitalization.

You may qualify if:

  • Infants under 2 years
  • Infants consulting at the emergency department of the University Hospital of Rennes for a first or second episode of bronchiolitis with criteria for hospitalization

You may not qualify if:

  • Children transferred from another department such as pediatric intensive care unit
  • Children for whom Wang's score could not be established
  • Child over 2 years old at diagnosis
  • Child with a 3rd episode of bronchiolitis or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Sylvaine Lefeuvre

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 15, 2017

First Posted

December 5, 2017

Study Start

October 1, 2015

Primary Completion

February 15, 2016

Study Completion

February 15, 2016

Last Updated

December 5, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)