Esophageal pH-MII Duration: 12 or 24 Hours?

Gastro Esophageal Reflux Clinical Trial

Official title:

Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760274
• Other study ID #: 5080
• Status: Recruiting
• Start date: July 13, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefano Nobile, MD, PhD, MSc
• Phone: +390630154357
• Email: stefano.nobile[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Diagnostic Test:
• multichannel 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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	bolus exposure index	As detected by manufacturer's software	comparison between the first 12 hours of the test and the whole duration (24 hours)
Primary	bolus clearance time	As detected by manufacturer's software	comparison between the first 12 hours of the test and the whole duration (24 hours)
Primary	symptom index	As detected by manufacturer's software	comparison between the first 12 hours of the test and the whole duration (24 hours)
Primary	symptom association probability	As detected by manufacturer's software	comparison between the first 12 hours of the test and the whole duration (24 hours)
Secondary	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)
Secondary	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	comparison between the first 12 hours of the test and the whole duration (24 hours)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)