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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
inhalation 4ml hypertonic saline 3% 3x/day
Intrapulmonary Percussive Ventilation
Assisted Autogenic Drainage
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, Wang score, Sa02, airway clearance techniques, intrapulmonary percussive ventilation, assisted autogenic drainage

Eligibility Criteria

1 Day - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uz Brussel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Intrapulmonary Percussive Ventilation

Assisted Autogenic Drainage

control

Arm Description

20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day

20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day

20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day

Outcomes

Primary Outcome Measures

Length of Hospital Stay
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

Wang Score
Heartrate
Oxygen Saturation (SaO2)
oxygen saturation (SaO2) measured by pulse -oximetry

Full Information

First Posted
April 24, 2014
Last Updated
March 10, 2015
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02126748
Brief Title
The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, Wang score, Sa02, airway clearance techniques, intrapulmonary percussive ventilation, assisted autogenic drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrapulmonary Percussive Ventilation
Arm Type
Experimental
Arm Description
20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Arm Title
Assisted Autogenic Drainage
Arm Type
Active Comparator
Arm Description
20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Arm Title
control
Arm Type
No Intervention
Arm Description
20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
Intervention Type
Other
Intervention Name(s)
inhalation 4ml hypertonic saline 3% 3x/day
Intervention Type
Device
Intervention Name(s)
Intrapulmonary Percussive Ventilation
Intervention Type
Procedure
Intervention Name(s)
Assisted Autogenic Drainage
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Description
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)
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Wang Score
Time Frame
before treatment, immediately after treatment and 1h after treatment
Title
Heartrate
Time Frame
before, after and 1h after intervention
Title
Oxygen Saturation (SaO2)
Description
oxygen saturation (SaO2) measured by pulse -oximetry
Time Frame
before, after and 1h after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Uz Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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