Clinical trial NCT05760274: Esophageal pH-MII Duration: 12 or 24 Hours?
Official title: Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro Esophageal Reflux
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 127
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants 0-12 months who underwent 24 hour MII-pH for suspected GER

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.

Eligibility 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, 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

Primary outcomes:
measure: number of GER episodes
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: number of GER episodes reaching the proximal esophagus
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: time with pH<4
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: bolus exposure index
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: bolus clearance time
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: symptom index
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: symptom association probability
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
Secondary outcomes:
measure: number of GER episodes: subgroup analysis based on gestational age at birth, diagnosis of bronchopulmonary dysplasia (BPD), prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: number of GER episodes reaching the proximal esophagus: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: time with pH<4: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: bolus exposure index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: bolus clearance time: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: symptom index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
measure: symptom association probability: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)
timeFrame: comparison between the first 12 hours of the test and the whole duration (24 hours)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Gemelli IRCCS
name: Stefano Nobile, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: