Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513890
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2007-08-08
Brief Title:
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didnt Require Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
1 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 deviceInfantflow during 6 hours group B is treated conventionally by inhalation of a AirO2 mixture during 6 hours
2 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 PaO2FiO2
3 Analyze results Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms clinical score
4 Calendar of the study October 2006 at April 2008
5 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
2 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 PaO2FiO2
3 Analyze results Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms clinical score
4 Calendar of the study October 2006 at April 2008
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None