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Safety Study of Airway Clearance Techniques in Infants.

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ClinicalTrials.gov Identifier: NCT02128867
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Filip Van Ginderdeuren, Vrije Universiteit Brussel

Brief Summary:
The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.

Condition or disease Intervention/treatment Phase
Gastro-esophageal Reflux Other: Assisted Autogenic Drainage (AAD) Other: bouncing and AAD Other: bouncing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Assisted Autogenic Drainage (AAD)
airway clearance technique for infants :Assisted Autogenic Drainage
Other: Assisted Autogenic Drainage (AAD)
Experimental: bouncing and AAD
airway clearance technique for infants : bouncing combined with AAD
Other: bouncing and AAD
Experimental: bouncing
bouncing . intervention to relax the infant
Other: bouncing



Primary Outcome Measures :
  1. Number of Refluxes [ Time Frame: 15 minutes ]
    number of refluxes will be counted over a period of 15 minutes ( treatment time )


Secondary Outcome Measures :
  1. Duration of Reflux Episodes [ Time Frame: 15 minutes ]
    duration of reflux episodes will be measured during 15 min of treatment time


Other Outcome Measures:
  1. Heartrate [ Time Frame: 15 minutes ]
    heartrate will be measured during 15 min of treatment time

  2. Sa02 [ Time Frame: 15 minutes ]
    SaO2 will be measured during 15 minutes of treatment time



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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • infants < 1 year
  • acid reflux monitoring

Exclusion Criteria:

  • gestational age <24 w
  • anti-reflux medication
  • Nissen fundoplication
  • no parental consent

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): NCT02128867


Locations
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Belgium
UZBrussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel

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Responsible Party: Filip Van Ginderdeuren, PT, Drs., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT02128867     History of Changes
Other Study ID Numbers: FVG001
First Posted: May 1, 2014    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Filip Van Ginderdeuren, Vrije Universiteit Brussel:
gastro-esophageal reflux
GOR
GER
airway clearance techniques

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases