Gastroesophageal Reflux and Cardiorespiratory Problems (CR-GER)

U

University of Turin

Status

Completed

Conditions

Bradycardia
Gastroesophageal Reflux Disease
Desaturation of Blood
Apnea Infants

Study type

Observational

Funder types

Other

Identifiers

NCT03053609
apnea-01

Details and patient eligibility

About

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.

Full 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).

Enrollment

72 patients

Sex

All

Ages

Under 3 months old

Volunteers

No 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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