Esophageal pH-MII Duration: 12 or 24 Hours?

Completed

• Conditions: Gastro Esophageal Reflux

• Registration Number: NCT05760274
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Study Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-08
• Primary Completion: 2025-02-15
• Study Completion: 2025-02-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bolus exposure index	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
symptom index	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
symptom association probability	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
number of GER episodes reaching the proximal esophagus	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
time with pH<4	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
number of GER episodes	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
bolus clearance time	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software

Secondary Outcome Measures

Name	Time	Method
time with pH<4: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
symptom association probability: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software. Range 0-100% (values ≥ 95% are significant).
symptom index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software. Range 0-100% (values ≥ 50% are significant).
number of GER episodes: subgroup analysis based on gestational age at birth, diagnosis of bronchopulmonary dysplasia (BPD), prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
number of GER episodes reaching the proximal esophagus: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
bolus exposure index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software
bolus clearance time: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)	comparison between the first 12 hours of the test and the whole duration (24 hours)	As detected by manufacturer's software

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy