NCT04775641

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
876

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

February 25, 2021

Last Update Submit

September 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Descriptive practice for children and neonates management in MRI

    3 monthes

Interventions

questionnaire

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All center perforing a paediatric discharge in Italy in the 2014

You may qualify if:

  • Uncooperative children \< 14 years old
  • premature babies

You may not qualify if:

  • collaborating children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00135, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

January 1, 2019

Primary Completion

February 15, 2019

Study Completion

September 30, 2019

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations