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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513890
• Other study ID #: UF 7873
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: October 23, 2013
• Start date: October 2006
• Est. completion date: February 2010

Study information

• Verified date: April 2012
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Distress

Intervention

Device:
• Infantflow [EME, Brighton, England]

Locations

Country	Name	City	State
France	Service réanimation Pédiatrique	Montpellier	Languedoc-Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
Primary	after the begining of the procedure.
Primary	The respiratory distress was evaluated with the modified Woods Clinical Asthma
Primary	Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
Secondary	Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.
Secondary	Manometric: Variation of esophageal pressure at H0 and H6.
Secondary	Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
Secondary	and 98%, transcutanée PCO2, PaO2/FiO2