- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02124863
Influence of IPV on GOR in Infants From 0 to 12 Months.
December 22, 2016 updated by: Filip Van Ginderdeuren, Vrije Universiteit Brussel
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants From 0 to 12 Months.
The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
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
-
-
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 from 0 to 12 months
- impedance monitoring
Exclusion Criteria:
- gestational age < 24w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intrapulmonary Percussive Ventilation
number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
|
20 min IPV freq 300/min, p 10cmH2O
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Refluxes
Time Frame: during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.
|
Every two hours after feeding, the number of refluxes during 20 minutes are measured.
The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV
|
during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: fili van ginderdeuren, Vrije Universiteit Brussel
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
September 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
April 25, 2014
First Posted (Estimate)
April 28, 2014
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
December 22, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FVG002
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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Clinical Trials on Intrapulmonary Percussive Ventilation
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Cliniques universitaires Saint-Luc- Université...Unknown
-
Augusta UniversityNot yet recruitingRespiratory Distress Syndrome in Premature Infant
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National Multiple Sclerosis CenterNational MS Center MelsbroekTerminated
-
University of FloridaWithdrawnCystic Fibrosis | Airway Clearance Impairment
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University Hospital, BordeauxCompletedRespiratory Distress Syndrome, NewbornFrance
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Soroka University Medical CenterUnknown
-
University Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, FranceRecruitingIdiopathic Pulmonary FibrosisFrance
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Shanghai 10th People's HospitalNot yet recruitingAirway Clearance ImpairmentChina
-
University Hospital, AntwerpFLUIDDA nv; Artesis University College, AntwerpUnknown
-
University Hospital, Clermont-FerrandUniversity Hospital, EstaingUnknown