Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux
Not Applicable
Completed
- Conditions
- Gastro-esophageal Reflux
- Interventions
- Other: expiration lente prolongée
- Registration Number
- NCT03341585
- Lead Sponsor
- Vrije Universiteit Brussel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Expiration Lente Prolongée 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 ).
- Primary Outcome Measures
Name Time Method number of refluxes 20 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Brussel
🇧🇪Jette, Brussels, Belgium