48 Hours Esophagal pH-monitoring With and Without Gaviscon | NCT02783378

Studies
48 Hours Esophagal pH-monitoring With and Without Gaviscon

NCT02783378

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

May 8, 2018Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Gastroesophageal Reflux

Interventions

Gaviscon Syrup

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2016Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

May 13, 2016

First Submission Date that Met QC Criteria

May 25, 2016

First Posted Date

May 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2018

Last Update Posted Date

May 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yvan Vandenplas, Prof. Dr, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gaviscon syrup	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gaviscon Syrup	Drug		Gaviscon syrup	natriumalginaat and natriumbicarbonaat BE386802.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel		Brussels		1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided