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Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

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ClinicalTrials.gov Identifier: NCT03341585
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Filip Van Ginderdeuren, Vrije Universiteit Brussel

November 9, 2017
November 14, 2017
June 8, 2018
June 7, 2018
January 1, 2021   (Final data collection date for primary outcome measure)
number of refluxes [ Time Frame: 20 minutes ]
Same as current
Complete list of historical versions of study NCT03341585 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux
Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastro-esophageal Reflux
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).
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 ).
Intervention: Other: expiration lente prolongée
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Same as current
January 1, 2021
January 1, 2021   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
up to 365 Days   (Child)
No
Contact: filip van ginderdeuren, PhD +3224763916 filip.vanginderdeuren@uzbrussel.be
Contact: Marie-Laure Sibret, MSc +32487463689 msibret@vub.be
Belgium
 
 
NCT03341585
FVG005
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Filip Van Ginderdeuren, Vrije Universiteit Brussel
Vrije Universiteit Brussel
Not Provided
Principal Investigator: filip van ginderdeuren, PhD Vrije Universiteit Brussel
Vrije Universiteit Brussel
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP