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Completed

NCT Number: NCT03346174

Influence of Airway Clearance Techniques on GOR in Infants

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.

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Key information

Conditions

Gastro-oesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

1 day–365 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZBrussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 ).

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 ).

Primary outcomes

  1. number of refluxes

    Time frame: 20 minutes

Secondary outcomes

  1. number of acid refluxes

    Time frame: 20 minutes

Other outcomes

  1. number of non-acid refluxes

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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