Gastroesophageal Reflux and Cardiorespiratory Problems

Completed

• Conditions: Gastroesophageal Reflux Disease; Bradycardia; Desaturation of Blood; Apnea Infants

• Registration Number: NCT03053609
• Lead Sponsor: University of Turin, Italy

Brief 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.

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-10
• Last Update Submitted: 2017-02-10
• Study First Posted: 2017-02-15
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SAP index	calculated throughout 24 hours	Symptom Association Probability (SAP) between gastroesophageal reflux and cardio-respiratory events. SAP is considered positive if \> 95%.

Secondary Outcome Measures

Name	Time	Method
Gastroesophageal reflux frequency	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

Trial Locations

Locations (1)

Ospedale S.Anna di Torino; 🇮🇹 Torino, (to), Italy