BronchiolitisNCT00513890
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
A study testing Infantflow [EME, Brighton, England] in people with Bronchiolitis and Respiratory Distress, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Bronchiolitis, Respiratory Distress
- What is being tested?
- Infantflow [EME, Brighton, England]
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Feb 2010
- Phase
- Interventional
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant from 0 to 6 months admitted in the PICU
- Clinical diagnosis: bronchiolitis
- Signs of respiratory distress evaluated with a clinical score of respiratory distress > 4
Who cannot join
- Cardiopathy, cystic fibrosis or a neuromuscular desease
- Need for mechanical ventilation
Trial locations and contacts
1 site in 1 country.
France1 site
Service réanimation Pédiatrique
Montpellier, Languedoc-Roussillon, 34000
About this study
Official title: Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation
The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.
Read the detailed description
- Experimental plan: The infants (0 to 6 month) admitted in pediatric intesive care unit for respiratory distress with bronchiolitis but not requiring mechanical ventilation are randomized in two groups: group "A" is treated with a non-invasive ventilation device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of a Air/O2 mixture during 6 hours.
- Outcome: Primary outcome: clinical score of respiratory distress at H0 and H6. Secondary outcome: respiratory and cardiac frequency, average blood pressure. Manometric: Variation of esophageal pressure at H0, H6. Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94 and 98%, transcutaneus PCO2, PaO2/FiO2
- Analyze results: Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms (clinical score).
- Calendar of the study: October 2006 at April 2008
- Follow-up of the patients: the study proceeds during the hospitalization of the infants during 6 hours and will not impose any specific follow-up.
- Conditions
- Bronchiolitis, Respiratory Distress
- Being tested
- Infantflow [EME, Brighton, England]
- Keywords
- Bronchiolitis, Esophageal pressure mesurement, Clinical score, Citical care, Infant
- Medical subject headings
- Bronchiolitis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infantflow [EME, Brighton, England]Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
after the begining of the procedure.
The respiratory distress was evaluated with the modified Woods Clinical Asthma
Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
Secondary outcomes (4)
Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.
Manometric: Variation of esophageal pressure at H0 and H6.
Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
and 98%, transcutanée PCO2, PaO2/FiO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionFeb 2010
- Study completionFeb 2010
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 University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PICAUD Jean Charles, Doctor, Principal investigator, Service de réanimation pédiatrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513890
- Sponsor's protocol ID
- UF 7873
- Status last verified
- Apr 2012
- First submitted
- 8 Aug 2007
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00513890
- Acronym / sponsor ID
- UF 7873
- Conditions
- Bronchiolitis, Respiratory Distress
- Keywords
- Bronchiolitis, Esophageal pressure mesurement, Clinical score, Citical care, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Aug 2007 (estimated)
- 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.
The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.
Detailed description
- Experimental plan: The infants (0 to 6 month) admitted in pediatric intesive care unit for respiratory distress with bronchiolitis but not requiring mechanical ventilation are randomized in two groups: group "A" is treated with a non-invasive ventilation device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of a Air/O2 mixture during 6 hours.
- Outcome: Primary outcome: clinical score of respiratory distress at H0 and H6. Secondary outcome: respiratory and cardiac frequency, average blood pressure. Manometric: Variation of esophageal pressure at H0, H6. Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94 and 98%, transcutaneus PCO2, PaO2/FiO2
- Analyze results: Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms (clinical score).
- Calendar of the study: October 2006 at April 2008
- Follow-up of the patients: the study proceeds during the hospitalization of the infants during 6 hours and will not impose any specific follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant from 0 to 6 months admitted in the PICU
- Clinical diagnosis: bronchiolitis
- Signs of respiratory distress evaluated with a clinical score of respiratory distress > 4
Key exclusion criteria (2 listed)
- Cardiopathy, cystic fibrosis or a neuromuscular desease
- Need for mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infantflow [EME, Brighton, England] | Device | – |
Primary outcome
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
after the begining of the procedure.
The respiratory distress was evaluated with the modified Woods Clinical Asthma
Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
4 secondary outcomes
Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.
Manometric: Variation of esophageal pressure at H0 and H6.
Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
and 98%, transcutanée PCO2, PaO2/FiO2
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 24 Oct 2013.
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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.
PICAUD Jean Charles, Doctor principal investigator
Service de réanimation pédiatrique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infantflow [EME, Brighton, England] in people with Bronchiolitis and Respiratory Distress, run by University Hospital, Montpellier 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 3 inclusion and 2 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 24 Oct 2013. 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?
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6). The study lists 4 primary outcomes in all. 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 24 Oct 2013.