Back to resultsInfluence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).
Primary Purpose
Gastro-oesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
sitting position
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-oesophageal Reflux focused on measuring gastro-oesophageal reflux, intrapulmonary percussive ventilation, positioning
Eligibility Criteria
Inclusion Criteria:
- Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR)
Exclusion Criteria:
- : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Sites / Locations
- UZBrussel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
sitting position
Arm Description
infants are in a sitting position for 20 minutes
Outcomes
Primary Outcome Measures
number of reflux episodes
number of reflux episodes is counted over 20 min period of time
Secondary Outcome Measures
Full Information
NCT ID
NCT02620241
First Posted
November 30, 2015
Last Updated
November 6, 2017
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02620241
Brief Title
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).
Official Title
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
5. Study Description
Brief Summary
The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a stable upright position during 20 min. This is an addendum to the previous study with record number clinical trials.gov NCT02124863
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-oesophageal Reflux
Keywords
gastro-oesophageal reflux, intrapulmonary percussive ventilation, positioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sitting position
Arm Type
Other
Arm Description
infants are in a sitting position for 20 minutes
Intervention Type
Other
Intervention Name(s)
sitting position
Primary Outcome Measure Information:
Title
number of reflux episodes
Description
number of reflux episodes is counted over 20 min period of time
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR)
Exclusion Criteria:
: prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Facility Information:
Facility Name
UZBrussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).
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