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.
Study Type
OBSERVATIONAL
Enrollment
127
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.
Fondazione Policlinico Gemelli IRCCS
Roma, Italy
number of GER episodes
As detected by manufacturer's software
Time frame: 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
Time frame: 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
Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
bolus exposure index
As detected by manufacturer's software
Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
bolus clearance time
As detected by manufacturer's software
Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
symptom index
As detected by manufacturer's software
Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
symptom association probability
As detected by manufacturer's software
Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
number of GER episodes: subgroup analysis based on gestational age at birth, diagnosis of bronchopulmonary dysplasia (BPD), prevalent symptoms (respiratory or gastrointestinal)
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As detected by manufacturer's software
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)