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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02126748
First Posted: April 30, 2014
Last Update Posted: March 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Filip Van Ginderdeuren, Vrije Universiteit Brussel
  Purpose
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 Intervention
Bronchiolitis Other: inhalation 4ml hypertonic saline 3% 3x/day Device: Intrapulmonary Percussive Ventilation Procedure: Assisted Autogenic Drainage

Study Type: Interventional
Study Design: 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.

Further study details as provided by Filip Van Ginderdeuren, Vrije Universiteit Brussel:

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


Enrollment: 103
Study Start Date: December 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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
Belgium
Uz Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
  More Information

Responsible Party: Filip Van Ginderdeuren, PT,Drs, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT02126748     History of Changes
Other Study ID Numbers: FVG003
First Submitted: April 24, 2014
First Posted: April 30, 2014
Results First Submitted: February 23, 2015
Results First Posted: March 11, 2015
Last Update Posted: March 30, 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:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases