Italian Survey on Paediatric and Neonatal MRI | NCT04775641

Studies
Italian Survey on Paediatric and Neonatal MRI

NCT04775641

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Oct 6, 2021Actual

Enrollment

876Actual

Phase

Not provided

Conditions

Cerebral Disorders Congenital
Premature Birth

Interventions

questionnaire

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

Sep 2021

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 1, 2019Actual

Primary Completion Date

Feb 15, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 1, 2021Actual

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

Sep 29, 2021

Last Update Posted Date

Oct 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SPINAZZOLA GIORGIA, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this environment. In this active call survey, the authors sought to delineate the Italian situation regarding national centers, staff involved, monitoring and tools available. The primary aim was to evaluate clinical practice in childhood management in Magnetic Resonance suite.

This study was designed as prospective phone survey on the setting of a complete sample of all national centers performing almost a paediatric discharge in the 2014, obtained from Italian Health Ministery registers.

The three section survey was fill out with the Physician in charge in Magnetic Resonance suite. The Main outcome was a descriptive and exploratory analyses about the organization setting of the Centers (procedures, performers, monitoring and tools).

Detailed Description

Not provided

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

876Actual

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Descriptive practice for children and neonates management in MRI		3 monthes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uncooperative children < 14 years old
premature babies

Exclusion Criteria:

. collaborating children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Years

Standard Ages

Child

Study Population

All center perforing a paediatric discharge in Italy in the 2014

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Gemelli		Rome		00135	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36056321	Derived	Sbaraglia F, Spinazzola G, Adduci A, Continolo N, De Riso M, Ferrone G, Festa R, Garra R, Tosi F, Rossi M. Children and neonates anesthesia in magnetic resonance environment in Italy: an active call survey. BMC Anesthesiol. 2022 Sep 2;22(1):279. doi: 10.1186/s12871-022-01821-3.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms