Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

Vrije Universiteit Brussel

Status: Completed

Conditions: Gastro-esophageal Reflux

Treatments: Other: expiration lente prolongée

Study type: Interventional

Funder types: Other

Identifiers

NCT03341585

FVG005

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 1 to 365 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

55 participants in 1 patient group

Expiration Lente Prolongée

Experimental group

Description:

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 ).

Treatment:

Other: expiration lente prolongée