Gastroesophageal Reflux and Cardiorespiratory Problems

Study Overview
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Brief Summary
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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
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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).

Official Title
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Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.

Conditions
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Gastroesophageal Reflux Disease, Apnea Infants, Desaturation of Blood, Bradycardia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAP index | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnea, gastroesophageal reflux, bradycardia, desaturation, impedance