- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341585
Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux
December 15, 2020 updated by: Filip Van Ginderdeuren, Vrije Universiteit Brussel
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Brussels
-
Jette, Brussels, Belgium, 1090
- UZ Brussel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 year (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 ).
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of refluxes
Time Frame: 20 minutes
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Filip Van Ginderdeuren, PhD, Vrije Universiteit Brussel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 7, 2018
Primary Completion (ACTUAL)
December 15, 2020
Study Completion (ACTUAL)
December 15, 2020
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (ACTUAL)
November 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 15, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FVG005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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