Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|