48 Hours Esophagal pH-monitoring With and Without Gaviscon

Gastroesophageal Reflux Clinical Trial

Official title:

48 Hoursesophagal pH-monitoring With and Without Gaviscon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783378
• Other study ID #: B.U.N. 143201627026
• Status: Completed
• Phase: N/A
• Start date: February 24, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Gaviscon Syrup

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pathological GERD	change in pathological GERD from baseline at 24 and 48 hours	24 and 48 hours
Secondary	Effect of Gaviscon on pain in infants with GERD	Pain assessed via FLACC scale	24 and 48 hours
Secondary	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