BronchiolitisNCT03362125
Bronchiolitis: Evaluation of Wang's Score as a Predictor of the Duration of Oxygen Therapy in Bronchiolitis
An observational study of Bronchiolitis, run by Rennes University Hospital at 1 site in France.
Trial summary
Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to 15 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis
Read the detailed description
Bronchiolitis is a viral disease of very variable evolution going from a simple outpatient treatment to the necessity of hospitalization in intensive care.
This epidemic disease is found all year round with a seasonal peak from mid-October to late winter.
The risk factors for progression to severe or prolonged bronchiolitis have been highlighted, but the duration of hospitalization is difficult to predict, which leads to organizational difficulties in the services and additional anxiety for the families.
The management of beds during winter epidemics can be a source of difficulties for hospitalization services, with the need to temporarily increase reception places or transfer children to other hospitals.
Oxygen rescue is the main factor limiting the discharge of the pediatric ward. This criterion seems to us more suitable than the total duration of hospitalization.
Indeed, other factors such as the family environment or food difficulties can delay the child's departure from the service. Their assessment seems to be more subjective, their assessment may vary from one doctor to another.
Better management of beds during winter epidemics could help to avoid changes in service during hospitalization, thus facilitating relationships between caregivers and families.
- Conditions
- Bronchiolitis
- Medical subject headings
- Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through oxygen therapy completion an average of 82 hours
Secondary outcomes (3)
length of hospital stay
Relationship between length of hospital stay in hours and Wang's score
Measured: until the end of hospitalization an average of 10 days
use of oxygen therapy
Relationship between use of oxygen therapy and Wang's score
Measured: until the end of hospitalization an average of 10 days
transfer in intensive care
Relationship between secondary transfer in intensive care and Wang's score
Measured: until the end of hospitalization an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Oct 2015
- Primary completion15 Feb 2016
- Study completion15 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvaine Lefeuvre, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362125
- Sponsor's protocol ID
- 35RC15_3022 BRONCHOLITE
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchiolitis: Evaluation of Wang's Score as a Predictor of the Duration of Oxygen Therapy in Bronchiolitis
- ClinicalTrials.gov ID
- NCT03362125
- Acronym / sponsor ID
- 35RC15_3022 BRONCHOLITE
- Conditions
- Bronchiolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 15 Feb 2016 (actual)
- Study completion
- 15 Feb 2016 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis
Detailed description
Bronchiolitis is a viral disease of very variable evolution going from a simple outpatient treatment to the necessity of hospitalization in intensive care.
This epidemic disease is found all year round with a seasonal peak from mid-October to late winter.
The risk factors for progression to severe or prolonged bronchiolitis have been highlighted, but the duration of hospitalization is difficult to predict, which leads to organizational difficulties in the services and additional anxiety for the families.
The management of beds during winter epidemics can be a source of difficulties for hospitalization services, with the need to temporarily increase reception places or transfer children to other hospitals.
Oxygen rescue is the main factor limiting the discharge of the pediatric ward. This criterion seems to us more suitable than the total duration of hospitalization.
Indeed, other factors such as the family environment or food difficulties can delay the child's departure from the service. Their assessment seems to be more subjective, their assessment may vary from one doctor to another.
Better management of beds during winter epidemics could help to avoid changes in service during hospitalization, thus facilitating relationships between caregivers and families.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between the duration of oxygen therapy and Wang's score
Time frame: through oxygen therapy completion an average of 82 hours
Linear regression, to try to model the duration in hours of oxygen therapy according to Wang's score
3 secondary outcomes
length of hospital stay
Time frame: until the end of hospitalization an average of 10 days
use of oxygen therapy
Time frame: until the end of hospitalization an average of 10 days
transfer in intensive care
Time frame: until the end of hospitalization an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvaine Lefeuvre principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between the duration of oxygen therapy and Wang's score (time frame: through oxygen therapy completion an average of 82 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.