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

Study Overview
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Brief Summary
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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
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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. 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 Analyze results: Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms (clinical score). Calendar of the study: October 2006 at April 2008 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.

Official Title
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Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation

Conditions
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Bronchiolitis, Respiratory Distress

Intervention / Treatment
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* Device: Infantflow [EME, Brighton, England]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Infantflow [EME, Brighton, England]|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, Esophageal pressure mesurement, Clinical score, Citical care, Infant