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
  Purpose

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.


Condition Intervention
Bronchiolitis
Respiratory Distress
Device: Infantflow [EME, Brighton, England]

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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]

Secondary Outcome Measures:
  • 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

Enrollment: 19
Study Start Date: October 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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 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.
  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513890

Locations
France
Service réanimation Pédiatrique
Montpellier, Languedoc-Roussillon, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: PICAUD Jean Charles, Doctor Service de réanimation pédiatrique
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT00513890     History of Changes
Other Study ID Numbers: UF 7873
Study First Received: August 8, 2007
Last Updated: October 23, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Montpellier:
Bronchiolitis
Esophageal pressure mesurement
Clinical score
Citical care
Infant

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 21, 2014