CR-GER: Gastroesophageal Reflux and Cardiorespiratory Problems

Sponsor

University of Turin, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT03053609

Collaborator

(none)

Enrollment

Location

131

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Apnea Infants Desaturation of Blood Bradycardia

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 Design

Study Type:

Observational

Actual Enrollment :

72 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.

Actual Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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