NCT05760274

Esophageal pH-MII Duration: 12 or 24 Hours?

Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

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.

Detailed description

The results of the 24 hour MII-pH recording will be compared to those from the first 12 hour of the same study. To this end the study investigators will select the first 12 hour of the recording using the manufacturer's software (Diversatek Zvu Advanced GI Diagnostic Software). Published normal reference values will be used to confirm gastroesophageal reflux (GER). Appropriate statistical methods will be used to perform calculations. Subgroup analyses based on preterm birth, presence of bronchopulmonary dysplasia and type of prevalent GER symptom (respiratory or gastrointestinal) will be performed.

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-13
• Primary completion: 2025-02-15
• Completion: 2025-02-15
• First posted: 2023-03-08
• Last updated: 2025-03-11

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study