Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
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.
Device: Infantflow [EME, Brighton, England]
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation|
- 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]
- 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
|Study Start Date:||October 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513890
|Service réanimation Pédiatrique|
|Montpellier, Languedoc-Roussillon, France, 34000|
|Principal Investigator:||PICAUD Jean Charles, Doctor||Service de réanimation pédiatrique|