Gastroesophageal Reflux and Cardiorespiratory Problems | NCT03053609

Studies
Gastroesophageal Reflux and Cardiorespiratory Problems

NCT03053609

Sponsor

University of Turin, Italy

Status

Completed

Last Update Posted

Feb 15, 2017Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease
Apnea Infants
Desaturation of Blood
Bradycardia

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 10, 2017

First Posted Date

Feb 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2017

Last Update Posted Date

Feb 15, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesco Cresi, Principal Investigator, University of Turin, ItalyPrincipal Investigator

Lead Sponsor

University of Turin, ItalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francesco Cresi, MD, PhD	University of Turin, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale S.Anna di Torino		Torino	(to)	10126	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D001919	Bradycardia
D001049	Apnea

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

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Browse Branches

Not provided