Esophageal pH-MII Duration: 12 or 24 Hours?

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05760274
Study type	Observational
Source	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact	Stefano Nobile, MD, PhD, MSc
Phone	+390630154357
Email	stefano.nobile@policlinicogemelli.it
Status	Recruiting
Phase
Start date	July 13, 2022
Completion date	December 31, 2024

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