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Completed

NCT Number: NCT02126748

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

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uz Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhalation 4ml hypertonic saline 3% 3x/day

Other

intrapulmonary percussive ventilation

Device

Assisted Autogenic Drainage

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2014
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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