CompletedNot Applicable

Esophageal pH-MII Duration: 12 or 24 Hours?

Italy127 participantsStarted 2022-07-13

Plain-language summary

To check whether the first 12 hours of MII-pH recording are sufficient to diagnose gastroesophageal reflux disease (GERD) among newborns/infants, with a diagnostic accuracy similar to 24 hours of recording as currently advised.

Who can participate

Age range

1 Day – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 24 hours MII-pH performed for suspected GER Exclusion Criteria: * major malformations * previous thoraco-abdominal surgery, gastrostomy, anti-GERD therapy (thickeners, alginates, H2 blockers, proton pump inhibitor - PPIs, etc.) in the 7 days preceding the MII-pH, * ventilatory support (invasive or non-invasive) at the time of the MII-pH

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

number of GER episodes

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

number of GER episodes reaching the proximal esophagus

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

time with pH<4

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

bolus exposure index

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

bolus clearance time

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

symptom index

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

symptom association probability

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

Trial details

NCT IDNCT05760274

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-15

View on ClinicalTrials.gov More Gastro Esophageal Reflux trials

Who can participate

Age range

1 Day – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

number of GER episodes

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

number of GER episodes reaching the proximal esophagus

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

time with pH<4

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

bolus exposure index

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

bolus clearance time

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

symptom index

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)

symptom association probability

Timeframe: comparison between the first 12 hours of the test and the whole duration (24 hours)