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Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

Primary Purpose

Gastro-esophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
expiration lente prolongée
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro-esophageal Reflux

Eligibility Criteria

1 Day - 365 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants under the age of one year and on suspicion of GOR who were referred for 24h impedance-pH monitoring are included in this study.

Exclusion Criteria:

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

Sites / Locations

  • UZ Brussel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Expiration Lente Prolongée

Arm Description

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 'Expiration Lente Prolongée (ELPr)' . 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 ).

Outcomes

Primary Outcome Measures

number of refluxes

Secondary Outcome Measures

Full Information

First Posted
November 9, 2017
Last Updated
December 15, 2020
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03341585
Brief Title
Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux
Official Title
Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a specific airway clearance technique, l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in infants under the age of one year. Infants referred to hospital for a multichannel intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is only possible after signing the informal consent by one of the parents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-esophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expiration Lente Prolongée
Arm Type
Experimental
Arm Description
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 'Expiration Lente Prolongée (ELPr)' . 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 ).
Intervention Type
Other
Intervention Name(s)
expiration lente prolongée
Intervention Description
l'Expiration Lente Prolongée (ELPr) is a passive technique to enhance the expiration used in infants, obtained by a slow and increasing manual thoraco-abdominal pression applied at the end of a spontaneous expiration till the residual volume. The aim is to obtain a bigger expired volume compared to a normal expiration and drain the mucus out of the airways (Postiaux 2003). This technique has been invented by Guy Postiaux and is used in the Chest Physiotherapy (CPT).
Primary Outcome Measure Information:
Title
number of refluxes
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants under the age of one year and on suspicion of GOR who were referred for 24h impedance-pH monitoring are included in this study. Exclusion Criteria: prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
filip van ginderdeuren, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34568241
Citation
Lievens L, Vandenplas Y, Vanlaethem S, Van Ginderdeuren F. Prolonged Slow Expiration Technique and Gastroesophageal Reflux in Infants Under the Age of 1 Year. Front Pediatr. 2021 Sep 8;9:722452. doi: 10.3389/fped.2021.722452. eCollection 2021.
Results Reference
derived

Learn more about this trial

Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

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