Safety Study of Airway Clearance Techniques in Infants.

Gastro-esophageal Reflux Clinical Trial

Official title:

Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128867
• Other study ID #: FVG001
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: March 10, 2015
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 365 Days

Eligibility

Inclusion Criteria:

• infants < 1 year

• acid reflux monitoring

Exclusion Criteria:

• gestational age <24 w

• anti-reflux medication

• Nissen fundoplication

• no parental consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastro-esophageal Reflux
• Gastroesophageal Reflux

Intervention

Other:
• Assisted Autogenic Drainage (AAD)

• bouncing and AAD

• bouncing

Locations

Country	Name	City	State
Belgium	UZBrussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heartrate	heartrate will be measured during 15 min of treatment time	15 minutes	No
Other	Sa02	SaO2 will be measured during 15 minutes of treatment time	15 minutes	No
Primary	Number of Refluxes	number of refluxes will be counted over a period of 15 minutes ( treatment time )	15 minutes	No
Secondary	Duration of Reflux Episodes	duration of reflux episodes will be measured during 15 min of treatment time	15 minutes	No