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Completed

NCT Number: NCT02783378

48 Hours Esophagal pH-monitoring With and Without Gaviscon

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.

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Key information

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Brussels, 1090, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gaviscon Syrup

Drug

Other names: natriumalginaat and natriumbicarbonaat, BE386802.

Primary outcomes

  1. Incidence of pathological GERD

    Time frame: 24 and 48 hours

    change in pathological GERD from baseline at 24 and 48 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

48 Hoursesophagal pH-monitoring With and Without Gaviscon

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 26, 2016
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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