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Influence of Airway Clearance Techniques on GOR in Infants

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ClinicalTrials.gov Identifier: NCT03346174
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Filip Van Ginderdeuren, Vrije Universiteit Brussel

November 9, 2017
November 17, 2017
October 11, 2018
January 1, 2019
January 1, 2021   (Final data collection date for primary outcome measure)
number of refluxes [ Time Frame: 20 minutes ]
Same as current
Complete list of historical versions of study NCT03346174 on ClinicalTrials.gov Archive Site
number of acid refluxes [ Time Frame: 20 minutes ]
Same as current
number of non-acid refluxes [ Time Frame: 20 minutes ]
Same as current
 
Influence of Airway Clearance Techniques on GOR in Infants
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
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
Primary Purpose: Treatment
Gastro-oesophageal Reflux
  • Other: AAD
    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 ).
  • Other: BAAD
    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 ).
  • Experimental: AAD
    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.
    Intervention: Other: AAD
  • Experimental: BAAD
    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: Other: BAAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
150
January 1, 2021
January 1, 2021   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
up to 365 Days   (Child)
No
Contact: filip van ginderdeuren, PhD +3224763916 filip.vanginderdeuren@uzbrussel.be
Contact: Marie-Laure Sibret, MsC +32487463689 msibret@vub.be
Not Provided
 
 
NCT03346174
FVG004
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Filip Van Ginderdeuren, Vrije Universiteit Brussel
Vrije Universiteit Brussel
Not Provided
Principal Investigator: Filip Van Ginderdeuren, PhD Vrije Universiteit Brussel
Vrije Universiteit Brussel
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP