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

Not Applicable

Completed

• Conditions: Bronchiolitis; Respiratory Distress

• Registration Number: NCT00513890
• Lead Sponsor: University Hospital, Montpellier

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 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-04
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The respiratory distress was evaluated with the modified Woods Clinical Asthma
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
after the begining of the procedure.
Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]

Secondary Outcome Measures

Name	Time	Method
Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
and 98%, transcutanée PCO2, PaO2/FiO2
Manometric: Variation of esophageal pressure at H0 and H6.
Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.

Trial Locations

Locations (1)

Service réanimation Pédiatrique; 🇫🇷 Montpellier, Languedoc-Roussillon, France