NCT02126748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 11, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

April 24, 2014

Results QC Date

February 23, 2015

Last Update Submit

March 10, 2015

Conditions

Bronchiolitis

Keywords

bronchiolitisWang scoreSa02airway clearance techniquesintrapulmonary percussive ventilationassisted autogenic drainage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Wang Score

    before treatment, immediately after treatment and 1h after treatment

  • Heartrate

    before, after and 1h after intervention

  • Oxygen Saturation (SaO2)

    before, after and 1h after treatment

Study Arms (3)

Intrapulmonary Percussive Ventilation

EXPERIMENTAL

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

Other: inhalation 4ml hypertonic saline 3% 3x/dayDevice: Intrapulmonary Percussive Ventilation

Assisted Autogenic Drainage

ACTIVE COMPARATOR

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

Other: inhalation 4ml hypertonic saline 3% 3x/dayProcedure: Assisted Autogenic Drainage

control

NO INTERVENTION

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

Interventions

inhalation 4ml hypertonic saline 3% 3x/dayOTHER
Assisted Autogenic DrainageIntrapulmonary Percussive Ventilation
Intrapulmonary Percussive VentilationDEVICE
Intrapulmonary Percussive Ventilation
Assisted Autogenic DrainagePROCEDURE
Assisted Autogenic Drainage

Eligibility Criteria

Age1 Day - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • first period of wheezing
  • Wang score between 3 and 7
  • age \< 24 months
  • Sa02\> 90%

You may not qualify if:

  • ICU patients
  • mechanical ventilation
  • use of antibiotics
  • use of corticosteroids
  • gestational age \< 34 weeks
  • chronic cardiac or pulmonary disease
  • no parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uz Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

  • Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

    PMID: 37010196DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

InhalationSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHypertonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Filip Van Ginderdeuren
Organization
Vrije Universiteit Brussel
filip.vanginderdeuren@uzbrussel.be
+3224763916

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT,Drs

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 30, 2014

Study Start

December 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 11, 2015

Results First Posted

March 11, 2015

Record last verified: 2015-03

Locations

BE(1)