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

Bronchiolitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126748
• Other study ID #: FVG003
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: March 10, 2015
• Start date: December 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Other:
• inhalation 4ml hypertonic saline 3% 3x/day

Device:
• Intrapulmonary Percussive Ventilation

Procedure:
• Assisted Autogenic Drainage

Locations

Country	Name	City	State
Belgium	Uz Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 days	No
Secondary	Wang Score		before treatment, immediately after treatment and 1h after treatment	No
Secondary	Heartrate		before, after and 1h after intervention	No
Secondary	Oxygen Saturation (SaO2)	oxygen saturation (SaO2) measured by pulse -oximetry	before, after and 1h after treatment	No