Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

Gastro-esophageal Reflux Clinical Trial

Official title:

Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341585
• Other study ID #: FVG005
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2020
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 365 Days

Eligibility

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)

Related Conditions & MeSH terms

• Gastro-esophageal Reflux
• Gastroesophageal Reflux

Intervention

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).

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of refluxes		20 minutes