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

March 10, 2015 updated by: Filip Van Ginderdeuren, Vrije Universiteit Brussel

The Effectiveness of Assisted Autogenic Drainage (AAD) and Intrapulmonary Percussive Ventilation (IPV) to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis: a Randomised Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

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

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • UZ Brussel

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 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrapulmonary Percussive Ventilation
20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Other: inhalation 4ml hypertonic saline 3% 3x/day
Device: Intrapulmonary Percussive Ventilation
Active Comparator: Assisted Autogenic Drainage
20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Other: inhalation 4ml hypertonic saline 3% 3x/day
Procedure: Assisted Autogenic Drainage
No Intervention: control
20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: 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)
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wang Score
Time Frame: before treatment, immediately after treatment and 1h after treatment
before treatment, immediately after treatment and 1h after treatment
Heartrate
Time Frame: before, after and 1h after intervention
before, after and 1h after intervention
Oxygen Saturation (SaO2)
Time Frame: before, after and 1h after treatment
oxygen saturation (SaO2) measured by pulse -oximetry
before, after and 1h after treatment

Collaborators and Investigators

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

Sponsor

Vrije Universiteit Brussel

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

December 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVG003

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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