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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05760274
Other study ID # 5080
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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