Influence of Airway Clearance Techniques on GOR in Infants

Gastro-oesophageal Reflux Clinical Trial

Official title:

Influence of Assisted Autogenic Drainage (AAD) and Bouncing Combined With Assisted Autogenic Drainage (BAAD) on Acid and Non-acid Gastro-oesophageal Reflux (GOR) in Infants < 1 Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346174
• Other study ID #: FVG004
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: December 2020
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 365 Days

Eligibility

Inclusion Criteria:

• Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included

Exclusion Criteria:

• prematurity (gestational age less than 37 weeks),
• the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastro-oesophageal Reflux
• Gastroesophageal Reflux

Intervention

Other:
• AAD
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
• BAAD
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).

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	number of non-acid refluxes		20 minutes
Primary	number of refluxes		20 minutes
Secondary	number of acid refluxes		20 minutes