Gastro Esophageal Reflux
Conditions
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.
Interventions
DIAGNOSTIC_TESTmultichannel intraluminal impedance and pH monitoring (MII/pH)
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| bolus exposure index | 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 |
| symptom index | comparison between the first 12 hours of the test and the whole duration (24 hours) | As detected by manufacturer's software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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). |
| 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). |
Countries
Italy
Outcome results
None listed