Gastro Esophageal RefluxNCT05760274
Esophageal pH-MII Duration: 12 or 24 Hours?
An observational study of Gastro Esophageal Reflux, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- multichannel intraluminal impedance and pH monitoring (MII/pH)
- How many people
- 127 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jul 2022to 15 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: infants 0-12 months who underwent 24 hour MII-pH for suspected GER
Who may be able to join
- 24 hours MII-pH performed for suspected GER
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 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.
Read the 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.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- multichannel intraluminal impedance and pH monitoring (MII/pH)
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of GER episodes
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
number of GER episodes reaching the proximal esophagus
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
time with pH<4
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
bolus exposure index
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
bolus clearance time
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
symptom index
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
symptom association probability
As detected by manufacturer's software
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
Secondary outcomes (7)
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
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
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
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
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
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
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
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
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
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
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).
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
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).
Measured: comparison between the first 12 hours of the test and the whole duration (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start13 Jul 2022
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Nobile, MD, PhD, MSc, Principal investigator, Fondazione Policlinico Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760274
- Sponsor's protocol ID
- 5080
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Nobile S, Rotunno G, Vandenplas Y, Salvatore S, Ummarino D, Quitadamo P, Aceti A, Vento G; GER12 Study Group. Assessing the Reliability of 12- vs 24-Hour Esophageal pH-Impedance Monitoring for Gastroesophageal Reflux in Infants. Am J Gastroenterol. 2026 Aug 1;121(8):2026-2031. doi: 10.14309/ajg.0000000000003796. Epub 2025 Oct 13.
PubMed 41081569
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Esophageal pH-impedance Measurement in Newborns and Infants With Suspected Gastroesophageal Reflux: 12 or 24 Hours?
- ClinicalTrials.gov ID
- NCT05760274
- Acronym / sponsor ID
- 5080
- Conditions
- Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants 0-12 months who underwent 24 hour MII-pH for suspected GER
Key inclusion criteria (1 listed)
- 24 hours MII-pH performed for suspected GER
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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
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
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
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
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
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
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
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41081569Nobile S, Rotunno G, Vandenplas Y, Salvatore S, Ummarino D, Quitadamo P, Aceti A, Vento G; GER12 Study Group. Assessing the Reliability of 12- vs 24-Hour Esophageal pH-Impedance Monitoring for Gastroesophageal Reflux in Infants. Am J Gastroenterol. 2026 Aug 1;121(8):2026-2031. doi: 10.14309/ajg.0000000000003796. Epub 2025 Oct 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Nobile, MD, PhD, MSc principal investigator
Fondazione Policlinico Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of GER episodes (time frame: comparison between the first 12 hours of the test and the whole duration (24 hours)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.