Gastroesophageal Reflux and Cardiorespiratory Problems

Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03053609

Acronym

CR-GER

Enrollment

Registered

2017-02-15

Start date

2006-01-31

Completion date

2016-12-31

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

gastroesophageal reflux, apnea, bradycardia, desaturation, impedance

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results