Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- bolus exposure index
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 1 Day to 12 Months (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
bolus exposure index
Time Frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
symptom index
Time Frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
symptom association probability
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
bolus clearance time
Time Frame: comparison between the first 12 hours of the test and the whole duration (24 hours)
As detected by manufacturer's software
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))