Back to resultsInfluence of Airway Clearance Techniques on GOR in Infants
Primary Purpose
Gastro-oesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
AAD
BAAD
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-oesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included
Exclusion Criteria:
- prematurity (gestational age less than 37 weeks),
- the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Sites / Locations
- UZBrussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AAD
BAAD
Arm Description
AAD is an airway clearance technique for infants based upon the principles of autogenic drainage. By modulating manually the functional breathing level within the vital capacity, optimal airflow will be obtained at the targeted airway generations, where secretions have been identified. A gentle increase of manual pressure on the chest during each inspiration is performed to guide the breathing of the patient towards the desired lung volume level. During expiration the breathing movement of the patient is followed gently.
AAD is an airway clearance technique for infants based upon the principles of autogenic drainage .AAD sometimes leads to crying or resistance against therapy.Bouncing (at low amplitude:6-8 cm) in a stable upright position is a gentle up-and-down movement on a physio ball. It is not an ACT, but used to maximize the relaxation of the infant, avoiding resistance against or crying during treatment. Due to the relaxing effect of bouncing, infants appear to tolerate better AAD, increasing the effectiveness of the treatment.
Outcomes
Primary Outcome Measures
number of refluxes
Secondary Outcome Measures
number of acid refluxes
Full Information
NCT ID
NCT03346174
First Posted
November 9, 2017
Last Updated
December 15, 2020
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03346174
Brief Title
Influence of Airway Clearance Techniques on GOR in Infants
Official Title
Influence of Assisted Autogenic Drainage (AAD) and Bouncing Combined With Assisted Autogenic Drainage (BAAD) on Acid and Non-acid Gastro-oesophageal Reflux (GOR) in Infants < 1 Year
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-oesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAD
Arm Type
Experimental
Arm Description
AAD is an airway clearance technique for infants based upon the principles of autogenic drainage. By modulating manually the functional breathing level within the vital capacity, optimal airflow will be obtained at the targeted airway generations, where secretions have been identified. A gentle increase of manual pressure on the chest during each inspiration is performed to guide the breathing of the patient towards the desired lung volume level. During expiration the breathing movement of the patient is followed gently.
Arm Title
BAAD
Arm Type
Experimental
Arm Description
AAD is an airway clearance technique for infants based upon the principles of autogenic drainage .AAD sometimes leads to crying or resistance against therapy.Bouncing (at low amplitude:6-8 cm) in a stable upright position is a gentle up-and-down movement on a physio ball. It is not an ACT, but used to maximize the relaxation of the infant, avoiding resistance against or crying during treatment. Due to the relaxing effect of bouncing, infants appear to tolerate better AAD, increasing the effectiveness of the treatment.
Intervention Type
Other
Intervention Name(s)
AAD
Intervention Description
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
Intervention Type
Other
Intervention Name(s)
BAAD
Intervention Description
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
Primary Outcome Measure Information:
Title
number of refluxes
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
number of acid refluxes
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
number of non-acid refluxes
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included
Exclusion Criteria:
prematurity (gestational age less than 37 weeks),
the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Van Ginderdeuren, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZBrussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Influence of Airway Clearance Techniques on GOR in Infants
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