Back to resultsInfluence of IPV on GOR in Infants From 0 to 12 Months.
Primary Purpose
Gastro-oesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intrapulmonary Percussive Ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-oesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- infants from 0 to 12 months
- impedance monitoring
Exclusion Criteria:
- gestational age < 24w
- anti-reflux medication
- Nissen fundoplication
- no parental consent
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intrapulmonary Percussive Ventilation
Arm Description
number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Outcomes
Primary Outcome Measures
Number of Refluxes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02124863
First Posted
April 24, 2014
Last Updated
December 22, 2016
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02124863
Brief Title
Influence of IPV on GOR in Infants From 0 to 12 Months.
Official Title
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants From 0 to 12 Months.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-oesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrapulmonary Percussive Ventilation
Arm Type
Experimental
Arm Description
number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Intervention Type
Device
Intervention Name(s)
Intrapulmonary Percussive Ventilation
Intervention Description
20 min IPV freq 300/min, p 10cmH2O
Primary Outcome Measure Information:
Title
Number of Refluxes
Description
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
Time Frame
during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
infants from 0 to 12 months
impedance monitoring
Exclusion Criteria:
gestational age < 24w
anti-reflux medication
Nissen fundoplication
no parental consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fili van ginderdeuren
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
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Influence of IPV on GOR in Infants From 0 to 12 Months.
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