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Completed

NCT Number: NCT05760274

Esophageal pH-MII Duration: 12 or 24 Hours?

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.

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Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multichannel intraluminal impedance and pH monitoring (MII/pH)

Diagnostic Test

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.

Primary outcomes

  1. number of GER episodes

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  2. number of GER episodes reaching the proximal esophagus

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  3. time with pH<4

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  4. bolus exposure index

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  5. bolus clearance time

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  6. symptom index

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  7. symptom association probability

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

Secondary outcomes

  1. number of GER episodes: subgroup analysis based on gestational age at birth, diagnosis of bronchopulmonary dysplasia (BPD), prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  2. number of GER episodes reaching the proximal esophagus: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  3. time with pH<4: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  4. bolus exposure index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  5. bolus clearance time: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software

  6. symptom index: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software. Range 0-100% (values ≥ 50% are significant).

  7. symptom association probability: subgroup analysis based on gestational age at birth, diagnosis of BPD, prevalent symptoms (respiratory or gastrointestinal)

    Time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)

    As detected by manufacturer's software. Range 0-100% (values ≥ 95% are significant).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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