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Clinical Trials/NCT03346174
NCT03346174CompletedNot 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 Brussel2 sites in 1 country105 target enrollmentStarted: February 1, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
2
Primary Endpoint
number of refluxes
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities

Eligibility Criteria

Ages
1 Day to 365 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Filip Van Ginderdeuren

Prof. Dr.

Vrije Universiteit Brussel

Study Sites (2)

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