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?

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.

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Diagnostic test: multichannel intraluminal impedance and pH monitoring (MII/pH)

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 Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

infants 0-12 months who underwent 24 hour MII-pH for suspected GER

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Stefano Nobile, MD, PhD, MSc, Fondazione Policlinico Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: 5080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes