Safety Study of Airway Clearance Techniques in Infants.

Vrije Universiteit Brussel

Status: Completed

Conditions: Gastro-esophageal Reflux

Treatments: Other: bouncing; Other: bouncing and AAD; Other: Assisted Autogenic Drainage (AAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02128867

FVG001

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 1 to 365 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• infants < 1 year
• acid reflux monitoring

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

Assisted Autogenic Drainage (AAD)

Experimental group

Description:

airway clearance technique for infants :Assisted Autogenic Drainage

Treatment:

Other: Assisted Autogenic Drainage (AAD)

bouncing and AAD

Experimental group

Description:

airway clearance technique for infants : bouncing combined with AAD

Treatment:

Other: bouncing and AAD

bouncing

Experimental group

Description:

bouncing . intervention to relax the infant

Treatment:

Other: bouncing