Back to resultsSafety Study of Airway Clearance Techniques in Infants.
Primary Purpose
Gastro-esophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Assisted Autogenic Drainage (AAD)
bouncing and AAD
bouncing
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-esophageal Reflux focused on measuring gastro-esophageal reflux, GOR, GER, airway clearance techniques
Eligibility Criteria
Inclusion Criteria:
- infants < 1 year
- acid reflux monitoring
Exclusion Criteria:
- gestational age <24 w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
Sites / Locations
- UZBrussel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Assisted Autogenic Drainage (AAD)
bouncing and AAD
bouncing
Arm Description
airway clearance technique for infants :Assisted Autogenic Drainage
airway clearance technique for infants : bouncing combined with AAD
bouncing . intervention to relax the infant
Outcomes
Primary Outcome Measures
Number of Refluxes
number of refluxes will be counted over a period of 15 minutes ( treatment time )
Secondary Outcome Measures
Duration of Reflux Episodes
duration of reflux episodes will be measured during 15 min of treatment time
Full Information
NCT ID
NCT02128867
First Posted
April 23, 2014
Last Updated
March 10, 2015
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02128867
Brief Title
Safety Study of Airway Clearance Techniques in Infants.
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-esophageal Reflux
Keywords
gastro-esophageal reflux, GOR, GER, airway clearance techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assisted Autogenic Drainage (AAD)
Arm Type
Experimental
Arm Description
airway clearance technique for infants :Assisted Autogenic Drainage
Arm Title
bouncing and AAD
Arm Type
Experimental
Arm Description
airway clearance technique for infants : bouncing combined with AAD
Arm Title
bouncing
Arm Type
Experimental
Arm Description
bouncing . intervention to relax the infant
Intervention Type
Other
Intervention Name(s)
Assisted Autogenic Drainage (AAD)
Intervention Type
Other
Intervention Name(s)
bouncing and AAD
Intervention Type
Other
Intervention Name(s)
bouncing
Primary Outcome Measure Information:
Title
Number of Refluxes
Description
number of refluxes will be counted over a period of 15 minutes ( treatment time )
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Duration of Reflux Episodes
Description
duration of reflux episodes will be measured during 15 min of treatment time
Time Frame
15 minutes
Other Pre-specified Outcome Measures:
Title
Heartrate
Description
heartrate will be measured during 15 min of treatment time
Time Frame
15 minutes
Title
Sa02
Description
SaO2 will be measured during 15 minutes of treatment time
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
infants < 1 year
acid reflux monitoring
Exclusion Criteria:
gestational age <24 w
anti-reflux medication
Nissen fundoplication
no parental consent
Facility Information:
Facility Name
UZBrussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
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Safety Study of Airway Clearance Techniques in Infants.
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