Influence of Airway Clearance Techniques on GOR in Infants

Not Applicable

Completed

• Conditions: Gastro-oesophageal Reflux
• Interventions: Other: AAD; Other: BAAD

• Registration Number: NCT03346174
• Lead Sponsor: Vrije Universiteit Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2019-02-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AAD	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.
BAAD	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.

Primary Outcome Measures

Name	Time	Method
number of refluxes	20 minutes

Secondary Outcome Measures

Name	Time	Method
number of acid refluxes	20 minutes

Trial Locations

Locations (1)

UZBrussel; 🇧🇪 Jette, Brussels, Belgium