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Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

NCT ID: NCT03341585

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Gastro-esophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expiration Lente Prolongée

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 ).

Group Type EXPERIMENTAL

expiration lente prolongée

Intervention Type OTHER

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).

Interventions

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expiration lente prolongée

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).

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

1 Day

Maximum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Filip Van Ginderdeuren

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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filip van ginderdeuren, PhD

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 34568241 (View on PubMed)

Other Identifiers

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FVG005

Identifier Type: -

Identifier Source: org_study_id