Esophageal pH-MII Duration: 12 or 24 Hours?

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Gastro Esophageal Reflux

Treatments: Diagnostic Test: multichannel intraluminal impedance and pH monitoring (MII/pH)

Study type: Observational

Funder types: Other

Identifiers

NCT05760274

5080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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