Clinical Trials Logo
  1. Home
  2. Respiratory Distress
  3. NCT00513890

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 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00513890
Study type Interventional
Source University Hospital, Montpellier
Contact
Status Completed
Phase N/A
Start date October 2006
Completion date February 2010
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04989114 - Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis N/A
Recruiting NCT06016244 - Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Recruiting NCT02366715 - Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research Phase 3
Terminated NCT02219334 - Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study N/A
Recruiting NCT01944995 - Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis N/A
Terminated NCT02834819 - Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis N/A
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Not yet recruiting NCT01414322 - Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT00347880 - Atrial and Brain Natriuretic Peptides in Bronchiolitis Phase 1
Recruiting NCT05548036 - A Feasibility RCT of Aerobika Verses ACBT in People With COPD N/A
Active, not recruiting NCT04302207 - The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study N/A
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Withdrawn NCT05994183 - The Bronchiolitis in Hospitalized Infants Study Early Phase 1
Terminated NCT03614507 - Automation Oxygen Flow Titration in Spontaneously Breathing Infants N/A
Completed NCT02856165 - High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis N/A
Recruiting NCT05909566 - Respiratory Support and Treatment for Efficient and Cost-Effective Care N/A
Recruiting NCT04437641 - Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
Not yet recruiting NCT06083077 - Chest and Abdominal Wall Strapping in Infant With Bronchiolitis N/A