Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

NCT03341585 | Completed

• 1 other identifier: FVG005
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-esophageal Reflux

Outcome Measures

Primary Outcomes (1)

• number of refluxes

  20 minutes

Study Arms (1)

Expiration Lente Prolongée

EXPERIMENTAL

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

Interventions

expiration lente prolongée 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).

Expiration Lente Prolongée

Eligibility Criteria

• Age: 1 Day - 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34568241 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• filip van ginderdeuren, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: June 7, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)