Safety Study of Airway Clearance Techniques in Infants.

March 10, 2015 updated by: Filip Van Ginderdeuren, Vrije Universiteit Brussel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • UZBrussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infants < 1 year
  • acid reflux monitoring

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Refluxes
Time Frame: 15 minutes
number of refluxes will be counted over a period of 15 minutes ( treatment time )
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Reflux Episodes
Time Frame: 15 minutes
duration of reflux episodes will be measured during 15 min of treatment time
15 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heartrate
Time Frame: 15 minutes
heartrate will be measured during 15 min of treatment time
15 minutes
Sa02
Time Frame: 15 minutes
SaO2 will be measured during 15 minutes of treatment time
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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