Back to resultsInterest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
Primary Purpose
Bronchiolitis, Respiratory Distress
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infantflow [EME, Brighton, England]
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Esophageal pressure mesurement, Clinical score, Citical care, Infant
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cardiopathy, cystic fibrosis or a neuromuscular desease
- Need for mechanical ventilation
Sites / Locations
- Service réanimation Pédiatrique
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
NCT ID
NCT00513890
First Posted
August 8, 2007
Last Updated
October 23, 2013
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT00513890
Brief Title
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
Official Title
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Respiratory Distress
Keywords
Bronchiolitis, Esophageal pressure mesurement, Clinical score, Citical care, Infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Infantflow [EME, Brighton, England]
Primary Outcome Measure Information:
Title
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
Title
after the begining of the procedure.
Title
The respiratory distress was evaluated with the modified Woods Clinical Asthma
Title
Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
Secondary Outcome Measure Information:
Title
Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.
Title
Manometric: Variation of esophageal pressure at H0 and H6.
Title
Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
Title
and 98%, transcutanée PCO2, PaO2/FiO2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Cardiopathy, cystic fibrosis or a neuromuscular desease
Need for mechanical ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PICAUD Jean Charles, Doctor
Organizational Affiliation
Service de réanimation pédiatrique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service réanimation Pédiatrique
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
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