Safety Study of Airway Clearance Techniques in Infants.

Vrije Universiteit Brussel159 enrolled

Overview

The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

159

Conditions

Gastro-esophageal Reflux

Interventions

Assisted Autogenic Drainage (AAD)OTHER

bouncing and AADOTHER

bouncingOTHER

Eligibility

Sex: ALLMin age: 1 DayMax age: 365 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * infants \< 1 year * acid reflux monitoring Exclusion Criteria: * gestational age \<24 w * anti-reflux medication * Nissen fundoplication * no parental consent

Locations (1)

UZBrussel

Jette, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Number of Refluxes

number of refluxes will be counted over a period of 15 minutes ( treatment time )

Time frame: 15 minutes

Secondary Outcomes

Duration of Reflux Episodes

duration of reflux episodes will be measured during 15 min of treatment time

Time frame: 15 minutes

Data from ClinicalTrials.gov

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