Safety Study of Airway Clearance Techniques in Infants.

Not Applicable

Completed

• Conditions: Gastro-esophageal Reflux
• Interventions: Other: Assisted Autogenic Drainage (AAD); Other: bouncing and AAD; Other: bouncing

• Registration Number: NCT02128867
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2015-02-23
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Results First Posted: 2015-03-17
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• infants < 1 year
• acid reflux monitoring

Exclusion Criteria

• gestational age <24 w
• anti-reflux medication
• Nissen fundoplication
• no parental consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assisted Autogenic Drainage (AAD)	Assisted Autogenic Drainage (AAD)	airway clearance technique for infants :Assisted Autogenic Drainage
bouncing and AAD	bouncing and AAD	airway clearance technique for infants : bouncing combined with AAD
bouncing	bouncing	bouncing . intervention to relax the infant

Primary Outcome Measures

Name	Time	Method
Number of Refluxes	15 minutes	number of refluxes will be counted over a period of 15 minutes ( treatment time )

Secondary Outcome Measures

Name	Time	Method
Duration of Reflux Episodes	15 minutes	duration of reflux episodes will be measured during 15 min of treatment time

Trial Locations

Locations (1)

UZBrussel; 🇧🇪 Jette, Brussels, Belgium