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

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ClinicalTrials.gov Identifier: NCT02126748
Recruitment Status : Completed
First Posted : April 30, 2014
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Filip Van Ginderdeuren, Vrije Universiteit Brussel

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: inhalation 4ml hypertonic saline 3% 3x/day Device: Intrapulmonary Percussive Ventilation Procedure: Assisted Autogenic Drainage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Wang Score [ Time Frame: before treatment, immediately after treatment and 1h after treatment ]
  2. Heartrate [ Time Frame: before, after and 1h after intervention ]
  3. Oxygen Saturation (SaO2) [ Time Frame: before, after and 1h after treatment ]
    oxygen saturation (SaO2) measured by pulse -oximetry


Eligibility Criteria
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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126748


Locations
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Belgium
Uz Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
More Information
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Responsible Party: Filip Van Ginderdeuren, PT,Drs, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT02126748    
Other Study ID Numbers: FVG003
First Posted: April 30, 2014    Key Record Dates
Results First Posted: March 11, 2015
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Filip Van Ginderdeuren, Vrije Universiteit Brussel:
bronchiolitis
Wang score
Sa02
 airway clearance techniques
intrapulmonary percussive ventilation
assisted autogenic drainage
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Respiratory Tract Infections
Infections
 Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Virus Diseases