Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
|ClinicalTrials.gov Identifier: NCT00513890|
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : October 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Respiratory Distress||Device: Infantflow [EME, Brighton, England]||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513890
|Service réanimation Pédiatrique|
|Montpellier, Languedoc-Roussillon, France, 34000|
|Principal Investigator:||PICAUD Jean Charles, Doctor||Service de réanimation pédiatrique|