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Esophageal pH-MII Duration: 12 or 24 Hours?

NCT05760274 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Gastro Esophageal Reflux

Interventions

DIAGNOSTIC_TEST

multichannel intraluminal impedance and pH monitoring (MII/pH)

A pH-MII probe is inserted nasally into the esophagus, and the position verified by chest radiograph. pH-MII data are evaluated using manufacturer's software, and each tracing is manually reviewed and validated.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Stefano Nobile, MD, PhD, MSc · Fondazione Policlinico Gemelli IRCCS

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2025-02-15
Completion
2025-02-15
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05760274 on ClinicalTrials.gov