Gastroesophageal Reflux and Cardiorespiratory Problems

Gastroesophageal Reflux Disease Clinical Trial

— CR-GER  

Official title:

Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053609
• Other study ID #: apnea-01
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: February 10, 2017
• Start date: January 2006
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Apnea Infants
• Bradycardia
• Desaturation of Blood
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Italy	Ospedale S.Anna di Torino	Torino	(to)

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAP index	Symptom Association Probability (SAP) between gastroesophageal reflux and cardio-respiratory events. SAP is considered positive if > 95%.	calculated throughout 24 hours
Secondary	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