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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-02-28

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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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.

Conditions

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Bronchiolitis Respiratory Distress

Keywords

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Bronchiolitis Esophageal pressure mesurement Clinical score Citical care Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Infantflow [EME, Brighton, England]

Intervention Type DEVICE

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PICAUD Jean Charles, Doctor

Role: PRINCIPAL_INVESTIGATOR

Service de réanimation pédiatrique

Locations

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Service réanimation Pédiatrique

Montpellier, Languedoc-Roussillon, France

Site Status

Countries

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France

Other Identifiers

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UF 7873

Identifier Type: -

Identifier Source: org_study_id