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Clinical Trials/NCT03346174
NCT03346174
Completed
Not Applicable

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

Vrije Universiteit Brussel1 site in 1 country105 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastro-oesophageal Reflux
Sponsor
Vrije Universiteit Brussel
Enrollment
105
Locations
1
Primary Endpoint
number of refluxes
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Filip Van Ginderdeuren

Prof. Dr.

Vrije Universiteit Brussel

Eligibility Criteria

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)

Outcomes

Primary Outcomes

number of refluxes

Time Frame: 20 minutes

Secondary Outcomes

  • number of acid refluxes(20 minutes)

Study Sites (1)

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