Esophageal pH-MIIduration: 12 or 24 Hours?
Study Details
Study Description
Brief Summary
To check whether the first 12 hours of MII-pH recording are sufficient to diagnose GERD among newborns/infants, with a diagnostic accuracy similar to 24 hours of recording as currently advised.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 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
Outcome Measures
Primary Outcome Measures
- 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
- symptom association probability [comparison between the first 12 hours of the test and the whole duration (24 hours)]
As detected by manufacturer's software
Secondary Outcome Measures
- number of GER episodes: 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
- 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
- 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
Eligibility Criteria
Criteria
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, PPIs, etc.) in the 7 days preceding the MII-pH,
-
ventilatory support (invasive or non-invasive) at the time of the MII-pH
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Gemelli IRCCS | Roma | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Stefano Nobile, MD, PhD, MSc, Fondazione Policlinico Gemelli IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5080