48 Hours Esophagal pH-monitoring With and Without Gaviscon
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gaviscon Syrup
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux focused on measuring impedance metry, gaviscon
Eligibility Criteria
Inclusion Criteria:
- children in whom a pH-monitoring was asked
- pre school-age children
- hospitalized children
- parents have the informed consent signed.
Exclusion criteria :
- children over 6 years
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Gaviscon syrup
Arm Description
Gaviscon will be given to threat patients with reflux after first 24 hours of oesophagal pH-monitoring. This is a syrup and will be given after every meal. dosage depends from age between 1ml and 5ml after every meal
Outcomes
Primary Outcome Measures
Incidence of pathological GERD
change in pathological GERD from baseline at 24 and 48 hours
Secondary Outcome Measures
Effect of Gaviscon on pain in infants with GERD
Pain assessed via FLACC scale
Effect of Gaviscon on parental concern for parents of infants with GERD
Parental concern assessed via 10 point Likert scale
Full Information
NCT ID
NCT02783378
First Posted
May 13, 2016
Last Updated
May 2, 2018
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02783378
Brief Title
48 Hours Esophagal pH-monitoring With and Without Gaviscon
Official Title
48 Hoursesophagal pH-monitoring With and Without Gaviscon
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours. During the first 24 hours are the measurements without medication. After 24 hours the treatment will be started with Gaviscon and will the next 24 hours the measurements under the medication happen. Normally is the medication required after the measurements. With this study the investigators will have multiple measurement points to compare.
Detailed Description
This is an interventional, with questionnaires. 25 participants will be included.
Parents and children must be willing to have the esophagal pH-monitoring for 48 hours instead of 24 hours.
The restrictions are (like any other esophagal pH-monitoring) :
Do not detach the probe, no bath or shower, no bouncy castle, no swimming pool, ....
Give your child time to get used to the probe. Give your child no carbonated beverages, limit sweets, avoid chewing gum!
Not study specific procedures : there will be placed a probe for the oesophagal pH-monitoring and this will be checked on children's radiology.
study specific procedures : questionnaires at specific times : Before start : SF 36 Every 6 hours during 48hours : FLACC Satisfaction scale at the start, after 1 day and after 2 days
Flowchart time 0: obtaining ICF, signed by both parents, placing of probe, explanation of questionnaires, completing SF36 and satisfaction scale time 6: FLACC time 12: FLACC time 18: FLACC time 24: FLACC, satisfaction scale, reading out pH monitoring from the first 24 hours, then starting of Gaviscon in function of the result. The Gaviscon is supplied by the service, at no cost to the patient time 30: FLACC time 36: FLACC time 42: FLACC time 48: FLACC, satisfaction scale, remove pH monitoring
Calculation of the number of participants :
since there is never such a study was carried out, we started this pilot study. An analysis will be carried out after 15 patients.
Analysis of the results :
the results of the first and second 24 hour data will be compared (automatically by computer analysis).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
impedance metry, gaviscon
7. Study Design
Primary Purpose
Diagnostic
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
Gaviscon syrup
Arm Type
Other
Arm Description
Gaviscon will be given to threat patients with reflux after first 24 hours of oesophagal pH-monitoring.
This is a syrup and will be given after every meal. dosage depends from age between 1ml and 5ml after every meal
Intervention Type
Drug
Intervention Name(s)
Gaviscon Syrup
Other Intervention Name(s)
natriumalginaat and natriumbicarbonaat, BE386802.
Primary Outcome Measure Information:
Title
Incidence of pathological GERD
Description
change in pathological GERD from baseline at 24 and 48 hours
Time Frame
24 and 48 hours
Secondary Outcome Measure Information:
Title
Effect of Gaviscon on pain in infants with GERD
Description
Pain assessed via FLACC scale
Time Frame
24 and 48 hours
Title
Effect of Gaviscon on parental concern for parents of infants with GERD
Description
Parental concern assessed via 10 point Likert scale
Time Frame
24 hours and 48 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children in whom a pH-monitoring was asked
pre school-age children
hospitalized children
parents have the informed consent signed.
Exclusion criteria :
children over 6 years
Facility Information:
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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48 Hours Esophagal pH-monitoring With and Without Gaviscon
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