Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2006-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Non-Nutritive Sucking on Gastroesophageal Reflux and Related Apneas in Symptomatic Preterm Infants
NCT02023216
Inclined Positioning and Infant Gastroesophageal Reflux
NCT04542239
Detection of Neonatal Bradycardia
NCT00950287
Effects of Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms.
NCT03031288
Cardio-respiratory Events in Preterm Infants During Transition
NCT04123691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* exclusive enteral feeding
* parents' informed consent
Exclusion Criteria
* 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
3 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Cresi
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Cresi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale S.Anna di Torino
Torino, (to), Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
apnea-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.