48 Hours Esophagal pH-monitoring With and Without Gaviscon

NCT ID: NCT02783378

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-24
• Study Completion Date: 2017-12-31

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).

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Gaviscon Syrup

Intervention Type: DRUG

Interventions

Gaviscon Syrup

Intervention Type: DRUG

Other Intervention Names

natriumalginaat and natriumbicarbonaat; BE386802.

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Yvan Vandenplas

Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UZ Brussel

Brussels, , Belgium

Countries

Belgium

Other Identifiers

B.U.N. 143201627026

Identifier Type: -

Identifier Source: org_study_id