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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multichannel intraluminal impedance and pH monitoring (MII/pH) | Diagnostic Test | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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infants 0-12 months who underwent 24 hour MII-pH for suspected GER
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Nobile, MD, PhD, MSc | Fondazione Policlinico Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41081569 | Derived | 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. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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) |
| D004066 | Digestive System Diseases |