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NCT04775641 Clinical Trial

Italian Survey on Paediatric and Neonatal MRI

Premature Birth Clinical Trial

Official title:
Children and Neonates Anaesthesia in Magnetic Resonance Environment in Italy. An Active Call Survey

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04775641
Other study ID # MRI001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date September 30, 2019

Study information
Verified date September 2021
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 876
Est. completion date September 30, 2019
Est. primary completion date February 15, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 14 Years
Eligibility Inclusion Criteria: - Uncooperative children < 14 years old - premature babies Exclusion Criteria: . collaborating children

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire
questionnaire

Locations
Country Name City State
Italy Fondazione Policlinico Gemelli Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Descriptive practice for children and neonates management in MRI 3 monthes
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