Influence of Airway Clearance Techniques on GOR in Infants

NCT03346174 | Completed

• 1 other identifier: FVG004
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-oesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• number of refluxes

  20 minutes

Secondary Outcomes (1)

• number of acid refluxes

  20 minutes

Other Outcomes (1)

• number of non-acid refluxes

  20 minutes

Study Arms (2)

AAD

EXPERIMENTAL

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.

Other: AAD

BAAD

EXPERIMENTAL

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.

Other: BAAD

Interventions

AAD OTHER

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

BAAD OTHER

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 ).

BAAD

Eligibility Criteria

• Age: 1 Day - 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• prematurity (gestational age less than 37 weeks),
• the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

UZBrussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Filip Van Ginderdeuren, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)