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Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

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ClinicalTrials.gov Identifier: NCT03341585
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Filip Van Ginderdeuren, Vrije Universiteit Brussel

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Gastro-esophageal Reflux Other: expiration lente prolongée Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 ).
 Other: 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).


Outcome Measures
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Primary Outcome Measures :
  1. number of refluxes [ Time Frame: 20 minutes ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341585


Contacts
Contact: filip van ginderdeuren, PhD +3224763916 filip.vanginderdeuren@uzbrussel.be
Contact: Marie-Laure Sibret, MSc +32487463689 msibret@vub.be

Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
Principal Investigator: filip van ginderdeuren, PhD Vrije Universiteit Brussel
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Filip Van Ginderdeuren, Prof.Dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03341585     History of Changes
Other Study ID Numbers: FVG005
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases