We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

48 Hours Esophagal pH-monitoring With and Without Gaviscon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02783378
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Yvan Vandenplas, Universitair Ziekenhuis Brussel

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Gaviscon Syrup Not Applicable

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).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 48 Hoursesophagal pH-monitoring With and Without Gaviscon
Actual Study Start Date : February 24, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Gaviscon syrup

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
Other Names:
  • natriumalginaat and natriumbicarbonaat
  • BE386802.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of pathological GERD [ Time Frame: 24 and 48 hours ]
    change in pathological GERD from baseline at 24 and 48 hours


Secondary Outcome Measures :
  1. Effect of Gaviscon on pain in infants with GERD [ Time Frame: 24 and 48 hours ]
    Pain assessed via FLACC scale

  2. Effect of Gaviscon on parental concern for parents of infants with GERD [ Time Frame: 24 hours and 48 hours ]
    Parental concern assessed via 10 point Likert scale


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783378


Locations
Layout table for location information
Belgium
UZ Brussel
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yvan Vandenplas, Prof. Dr, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02783378    
Other Study ID Numbers: B.U.N. 143201627026
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yvan Vandenplas, Universitair Ziekenhuis Brussel:
impedance metry
gaviscon
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents