Gastroesophageal Reflux DiseaseCR-GERNCT03053609
Gastroesophageal Reflux and Cardiorespiratory Problems
An observational study of Gastroesophageal Reflux Disease and Apnea Infants, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Gastroesophageal Reflux Disease, Apnea Infants, Desaturation of Blood
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Dec 2016
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants admitted to the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital from January 2006 to December 2016 who underwent 24h synchronized pH-impedance and cardiorespiratory monitoring for GER disease symptoms and cardiorespiratory events.
Who may be able to join
- synchronized MII-pH and cardio-respiratory monitoring lasting more than 12 hours, excluding meal periods;
- exclusive enteral feeding
- parents' informed consent
Who cannot join
- infectious, genetic, metabolic and neurological diseases
- ventilatory support and/or oxygen supplementation at the time of MII-pH/CR monitoring
- pharmacological therapies with effects on GER or apnoea during the week before MII-pH/CR monitoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.
Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.
Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and, whether this association is significant, to clarify the impact of GER on CR events.
Read the detailed description
This is an observational retrospective study to describe the association between cardiorespiratory (CR) and gastroesophageal reflux (GER) events in infants who underwent synchronized 24h Multichannel Intraluminal Impedance/pH-metry (MII/pH) and CR monitoring for GER disease symptoms and CR events. Data are collected from medical records and database of the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital (Turin).
The symptom association probability (SAP) index is used to identify those infants with significant associations between GER and CR events. In the group of infants with a positive SAP index the differences in reflux characteristics are compared according to whether a reflux preceded or followed a cardiorespiratory event (30 s time window).
- Keywords
- gastroesophageal reflux, apnea, bradycardia, desaturation, impedance
- Medical subject headings
- Gastroesophageal Reflux, Bradycardia, Apnea
What is being measured
The primary outcome is the main question the study is designed to answer.
SAP index
Symptom Association Probability (SAP) between gastroesophageal reflux and cardio-respiratory events. SAP is considered positive if > 95%.
Measured: calculated throughout 24 hours
Secondary outcomes (1)
Gastroesophageal reflux frequency
Reflux event is defined as: a drop of impedance to 50% of the basal value for at least 5 s, starting in the most distal channel and proceeding to one or more proximal channels and followed by a recovery of the impedance baseline values
Measured: calculated throughout 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2006
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Cresi, University of Turin, Italy
- Investigators
- Francesco Cresi, MD, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053609
- Sponsor's protocol ID
- apnea-01
- Acronym
- CR-GER
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.
- ClinicalTrials.gov ID
- NCT03053609
- Acronym / sponsor ID
- CR-GER / apnea-01
- Keywords
- gastroesophageal reflux, apnea, bradycardia, desaturation, impedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Feb 2017 (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.
Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.
Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and, whether this association is significant, to clarify the impact of GER on CR events.
Detailed description
This is an observational retrospective study to describe the association between cardiorespiratory (CR) and gastroesophageal reflux (GER) events in infants who underwent synchronized 24h Multichannel Intraluminal Impedance/pH-metry (MII/pH) and CR monitoring for GER disease symptoms and CR events. Data are collected from medical records and database of the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital (Turin).
The symptom association probability (SAP) index is used to identify those infants with significant associations between GER and CR events. In the group of infants with a positive SAP index the differences in reflux characteristics are compared according to whether a reflux preceded or followed a cardiorespiratory event (30 s time window).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants admitted to the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital from January 2006 to December 2016 who underwent 24h synchronized pH-impedance and cardiorespiratory monitoring for GER disease symptoms and cardiorespiratory events.
Key inclusion criteria (3 listed)
- synchronized MII-pH and cardio-respiratory monitoring lasting more than 12 hours, excluding meal periods;
- exclusive enteral feeding
- parents' informed consent
Key exclusion criteria (3 listed)
- infectious, genetic, metabolic and neurological diseases
- ventilatory support and/or oxygen supplementation at the time of MII-pH/CR monitoring
- pharmacological therapies with effects on GER or apnoea during the week before MII-pH/CR monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SAP index
Time frame: calculated throughout 24 hours
Symptom Association Probability (SAP) between gastroesophageal reflux and cardio-respiratory events. SAP is considered positive if > 95%.
1 secondary outcome
Gastroesophageal reflux frequency
Time frame: calculated throughout 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 15 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Not yet recruitingObservational study
Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty
Abdominoplasty, Diaphragm
Not yet recruiting
De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy
Omentopexy, Sleeve Gastrectomy
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.
Francesco Cresi, MD, PhD principal investigator
University of Turin, Italy
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 Gastroesophageal Reflux Disease and Apnea Infants, run by University of Turin, Italy 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 3 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 15 Feb 2017. 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?
SAP index (time frame: calculated throughout 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2017; AzTrials last refreshed its copy on 27 Oct 2026.