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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 25, 2014