Gastroesophageal Reflux Disease Clinical Trial
Official title:
Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.
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.
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).
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