Clinical trial NCT00513890: Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
Official title: Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Respiratory Distress
Keywords: Bronchiolitis
Esophageal pressure mesurement
Clinical score
Citical care
Infant
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
measure: after the begining of the procedure.
measure: The respiratory distress was evaluated with the modified Woods Clinical Asthma
measure: Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
Secondary outcomes:
measure: Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.
measure: Manometric: Variation of esophageal pressure at H0 and H6.
measure: Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
measure: and 98%, transcutanée PCO2, PaO2/FiO2
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Service réanimation Pédiatrique
state: Languedoc-Roussillon
Study officials:
affiliation: Service de réanimation pédiatrique
name: PICAUD Jean Charles, Doctor
role: PRINCIPAL_INVESTIGATOR
References: