Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT00513890
First received: August 8, 2007
Last updated: October 23, 2013
Last verified: April 2012

August 8, 2007
October 23, 2013
October 2006
February 2010   (final data collection date for primary outcome measure)
  • 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]
Same as current
Complete list of historical versions of study NCT00513890 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation

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.

  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 device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of a Air/O2 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, PaO2/FiO2
  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bronchiolitis
  • Respiratory Distress
Device: Infantflow [EME, Brighton, England]
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00513890
UF 7873
Yes
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: PICAUD Jean Charles, Doctor Service de réanimation pédiatrique
University Hospital, Montpellier
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP