NCT02128867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

April 23, 2014

Results QC Date

February 23, 2015

Last Update Submit

March 10, 2015

Conditions

Gastro-esophageal Reflux

Keywords

gastro-esophageal refluxGORGERairway clearance techniques

Outcome Measures

Primary Outcomes (1)

  • Number of Refluxes

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

    15 minutes

Secondary Outcomes (1)

  • Duration of Reflux Episodes

    15 minutes

Other Outcomes (2)

  • Heartrate

    15 minutes

  • Sa02

    15 minutes

Study Arms (3)

Assisted Autogenic Drainage (AAD)

EXPERIMENTAL

airway clearance technique for infants :Assisted Autogenic Drainage

Other: Assisted Autogenic Drainage (AAD)

bouncing and AAD

EXPERIMENTAL

airway clearance technique for infants : bouncing combined with AAD

Other: bouncing and AAD

bouncing

EXPERIMENTAL

bouncing . intervention to relax the infant

Other: bouncing

Interventions

Assisted Autogenic Drainage (AAD)OTHER
Assisted Autogenic Drainage (AAD)
bouncing and AADOTHER
bouncing and AAD
bouncingOTHER
bouncing

Eligibility Criteria

Age1 Day - 365 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants \< 1 year
  • acid reflux monitoring

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZBrussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
filip van ginderdeuren
Organization
vrije universiteit brussel
filip.vanginderdeuren@uzbrussel.be
+3224763916

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, Drs.

Study Record Dates

First Submitted

April 23, 2014

First Posted

May 1, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 17, 2015

Results First Posted

March 17, 2015

Record last verified: 2015-03

Locations

BE(1)