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

Arm | Intervention/treatment |
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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 ).
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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).
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- number of refluxes [ Time Frame: 20 minutes ]

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Ages Eligible for Study: | up to 365 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Contact: filip van ginderdeuren, PhD | +3224763916 | filip.vanginderdeuren@uzbrussel.be | |
Contact: Marie-Laure Sibret, MSc | +32487463689 | msibret@vub.be |
Principal Investigator: | filip van ginderdeuren, PhD | Vrije Universiteit Brussel |
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 |