Safety Study of Airway Clearance Techniques in Infants.

NCT ID: NCT02128867

Last Updated: 2015-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Gastro-esophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Assisted Autogenic Drainage (AAD)

airway clearance technique for infants :Assisted Autogenic Drainage

Group Type EXPERIMENTAL

Assisted Autogenic Drainage (AAD)

Intervention Type OTHER

bouncing and AAD

airway clearance technique for infants : bouncing combined with AAD

Group Type EXPERIMENTAL

bouncing and AAD

Intervention Type OTHER

bouncing

bouncing . intervention to relax the infant

Group Type EXPERIMENTAL

bouncing

Intervention Type OTHER

Interventions

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Assisted Autogenic Drainage (AAD)

Intervention Type OTHER

bouncing and AAD

Intervention Type OTHER

bouncing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* infants \< 1 year
* acid reflux monitoring

Exclusion Criteria

* gestational age \<24 w
* anti-reflux medication
* Nissen fundoplication
* no parental consent
Minimum Eligible Age

1 Day

Maximum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Filip Van Ginderdeuren

PT, Drs.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZBrussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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FVG001

Identifier Type: -

Identifier Source: org_study_id

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