Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans

Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans: a Retrospective, Longitudinal Study

The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.

Study Overview

• Status: Active, not recruiting
• Conditions: Magnetic Resonance Imaging

Detailed Description

Magnetic resonance imaging (MRI) is a non-invasive imaging technique that allows physicians to visualize our anatomy, generating high-quality pictures of our body's internal structure at many different angles. The principle behind MRI, known as nuclear magnetic resonance (NMR), revolves around hydrogen atoms (or protons) that can be found everywhere in our entire body, such as in bones, blood, organs, skin, muscles and more. Protons have their own magnetic moment and angular momentum, allowing them to spin in a certain direction. By subjecting these spinning protons to a strong magnetic field they will be oriented along the axis of the magnetic field, either with or against the direction of the magnetic field. MRI machines generate this field using a large magnet surrounding the patient. Electric gradient coils allow the strength of the field to be adjustable, usually around 0,5 or 1,5 tesla.

MRI has many advantages compared to other imaging techniques, i.e. CT (computed tomography), including the lack of radiation, the ability to show abnormalities of soft tissues, the ability to visualize blood flow, and contrasting agents that are less likely to cause adverse effects like allergic reactions. There are also some disadvantages or limitations, however: implants or metallic objects inside the body can make images unclear at best or harm the patient at worst; similarly, movements made by the patient can make images unclear as well. Lastly, MRI is a more expensive and slower technique compared to other imaging techniques.

Children undergoing an MRI are often sedated before being placed inside the machine. After the scan is over, the children will be brought to a recovery area, where they can slowly recover from the sedation until they are fully awake again. Some common side effects resulting from the sedation may be vomiting, drowsiness and/or dizziness.

The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.

• Study Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population for this study will be children between 6 months and 16 years old who have undergone an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February 2023.

Description

Inclusion Criteria:

• Children undergoing an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February 2023.
• Age between 6 months and 16 years

Exclusion Criteria:

• /

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence	Incidence of diagnostic MRI in childeren	Between 2016 and 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutical implications: diagnosis	Evaluating the presence of a diagnosis after this MRI investigation	Between 2016 and 2023
Therapeutical implications: treatment	Evaluating if the MRI investigation resulted in treatment (drug treatment, surgery or physiotherapy)	Between 2016 and 2023
Clinical indications	Evaluating the clinical indications for the MRI investigation	Between 2016 and 2023
Evaluation of body part	Evaluating which specific body parts are undergoing imaging	Between 2016 and 2023
Evaluation of symptoms	Evaluation of the pre-existing symptoms (vomiting, headache, developmental delay, sleep issures, swellings, seizures, balance problems, conduct disorders, febrile convulsions) that potentially lead to an MRI scan	Between 2016 and 2023
Clinical outcome: adverse event	Evaluation of the clinical outcome: adverse events	Between 2016 and 2023
Clinical outcome: surgery	Evaluation of the clinical outcome: surgery after MRI	Between 2016 and 2023
Clinical outcome: admission to hospital	Evaluation of the clinical outcome: admission to hospital	Between 2016 and 2023
Clinical outcome: mortality	Evaluation of the clinical outcome: mortality after MRI	Between 2016 and 2023
Evaluation of age	Evaluation of age in children: <2 years, 2-6 years and >6 years	Between 2016 and 2023
Influence of COVID-19 pandemic	Influence of COVID-19 pandemic (2020-2021 versus 2016-2017-2018-2019-2022-2023) on incidence, therapeutical implications and outcomes of MRI scans in children	Between 2016 and 2023

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Childeren
• Other Study ID Numbers: f/2023/045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No