Influence of Airway Clearance Techniques on GOR in Infants
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|ClinicalTrials.gov Identifier: NCT03346174|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastro-oesophageal Reflux||Other: AAD Other: BAAD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities|
|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|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
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.
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 ).
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.
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 ).
- number of refluxes [ Time Frame: 20 minutes ]
- number of acid refluxes [ Time Frame: 20 minutes ]
- number of non-acid refluxes [ Time Frame: 20 minutes ]
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): NCT03346174
|Contact: filip van ginderdeuren, PhDfirstname.lastname@example.org|
|Jette, Brussels, Belgium, 1090|
|Contact: Filip Van Ginderdeuren, drs +3224773916 email@example.com|
|Principal Investigator: Filip Van Ginderdeuren, PT, drs|
|Sub-Investigator: Sylvie Vanlaethem, PT|
|Sub-Investigator: Yvan Vandenplas, MD,PhD|
|Principal Investigator:||Filip Van Ginderdeuren, PhD||Vrije Universiteit Brussel|