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

October 23, 2013 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34000
        • Service réanimation Pédiatrique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: PICAUD Jean Charles, Doctor, Service de réanimation pédiatrique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 7873

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Infantflow [EME, Brighton, England]

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