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?
1 other identifier
observational
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2022
CompletedFirst Submitted
Initial submission to the registry
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2025
CompletedMarch 11, 2025
March 1, 2025
2.6 years
February 27, 2023
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (7)
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)
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)
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)
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)
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)
- +2 more secondary outcomes
Interventions
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.
Eligibility Criteria
infants 0-12 months who underwent 24 hour MII-pH for suspected GER
You may qualify if:
- hours MII-pH performed for suspected GER
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Gemelli IRCCS
Roma, 00168, Italy
Related Publications (1)
Nobile S, Rotunno G, Vandenplas Y, Salvatore S, Ummarino D, Quitadamo P, Aceti A, Vento G; GER12 Study Group. Assessing the Reliability of 12- vs 24-Hour Esophageal pH-Impedance Monitoring for Gastroesophageal Reflux in Infants. Am J Gastroenterol. 2025 Oct 13. doi: 10.14309/ajg.0000000000003796. Online ahead of print.
PMID: 41081569DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano Nobile, MD, PhD, MSc
Fondazione Policlinico Gemelli IRCCS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2023
First Posted
March 8, 2023
Study Start
July 13, 2022
Primary Completion
February 15, 2025
Study Completion
February 15, 2025
Last Updated
March 11, 2025
Record last verified: 2025-03