Gastroesophageal Reflux and Cardiorespiratory Problems (CR-GER)

February 10, 2017 updated by: Francesco Cresi, University of Turin, Italy

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • (to)
      • Torino, (to), Italy, 10126
        • Ospedale S.Anna di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • synchronized MII-pH and cardio-respiratory monitoring lasting more than 12 hours, excluding meal periods;
  • exclusive enteral feeding
  • parents' informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
calculated throughout 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroesophageal reflux frequency
Time Frame: calculated throughout 24 hours
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
calculated throughout 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Francesco Cresi, MD, PhD, University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • apnea-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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