Clinical trial NCT03053609: Gastroesophageal Reflux and Cardiorespiratory Problems
Official title: Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Apnea Infants
Desaturation of Blood
Bradycardia
Keywords: gastroesophageal reflux
apnea
bradycardia
desaturation
impedance
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 72
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants admitted to the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital from January 2006 to December 2016 who underwent 24h synchronized pH-impedance and cardiorespiratory monitoring for GER disease symptoms and cardiorespiratory events.

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).

Eligibility criteria: 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

Primary outcomes:
measure: SAP index
timeFrame: calculated throughout 24 hours
Secondary outcomes:
measure: Gastroesophageal reflux frequency
timeFrame: calculated throughout 24 hours
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale S.Anna di Torino
state: (to)
Study officials:
affiliation: University of Turin, Italy
name: Francesco Cresi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: