The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Other: inhalation 4ml hypertonic saline 3% 3x/day; Device: Intrapulmonary Percussive Ventilation; Procedure: Assisted Autogenic Drainage

• Registration Number: NCT02126748
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2015-02-23
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Results First Posted: 2015-03-11
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• first period of wheezing
• Wang score between 3 and 7
• age < 24 months
• Sa02> 90%

Exclusion Criteria

• ICU patients
• mechanical ventilation
• use of antibiotics
• use of corticosteroids
• gestational age < 34 weeks
• chronic cardiac or pulmonary disease
• no parental consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrapulmonary Percussive Ventilation	inhalation 4ml hypertonic saline 3% 3x/day	20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Intrapulmonary Percussive Ventilation	Intrapulmonary Percussive Ventilation	20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Assisted Autogenic Drainage	Assisted Autogenic Drainage	20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Assisted Autogenic Drainage	inhalation 4ml hypertonic saline 3% 3x/day	20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	6 days	Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)

Secondary Outcome Measures

Name	Time	Method
Wang Score	before treatment, immediately after treatment and 1h after treatment
Heartrate	before, after and 1h after intervention
Oxygen Saturation (SaO2)	before, after and 1h after treatment	oxygen saturation (SaO2) measured by pulse -oximetry

Trial Locations

Locations (1)

Uz Brussel; 🇧🇪 Jette, Brussels, Belgium