Gastroesophageal Reflux and Cardiorespiratory Problems

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Apnea Apnea Infants Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Deglutition Disorders Desaturation of Blood Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale S.Anna di Torino

Torino, (to), 10126, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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%.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.

Acronym: CR-GER

Important dates

Study start: 2006
Primary completion: 2016
Study completion: 2016
First posted: Feb 15, 2017
Registry last updated: Feb 15, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed