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Influence of Airway Clearance Techniques on GOR in Infants

NCT03346174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-12-17

No results posted yet for this study

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.

Conditions

  • Gastro-oesophageal Reflux

Interventions

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 ).

OTHER

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 ).

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • Filip Van Ginderdeuren, PhD · Vrije Universiteit Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
365 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-12-10
Completion
2020-12-10

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03346174 on ClinicalTrials.gov