48 Hours Esophagal pH-monitoring With and Without Gaviscon

Study Overview
=================
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).

Official Title
-----------------
48 Hoursesophagal pH-monitoring With and Without Gaviscon

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Gaviscon Syrup


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gaviscon syrup<br>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 | Drug: Gaviscon Syrup<br> <br> * Other names: BE386802.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pathological GERD | change in pathological GERD from baseline at 24 and 48 hours | 24 and 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Gaviscon on pain in infants with GERD | Pain assessed via FLACC scale | 24 and 48 hours | 
| Effect of Gaviscon on parental concern for parents of infants with GERD | Parental concern assessed via 10 point Likert scale | 24 hours and 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
impedance metry, gaviscon