Clinical trial NCT06278376: Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans
Official title: Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans: a Retrospective, Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Keywords: Magnetic Resonance Imaging
Childeren
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 410
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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:

* /

Primary outcomes:
measure: Incidence
timeFrame: Between 2016 and 2023
Secondary outcomes:
measure: Therapeutical implications: diagnosis
timeFrame: Between 2016 and 2023
measure: Therapeutical implications: treatment
timeFrame: Between 2016 and 2023
measure: Clinical indications
timeFrame: Between 2016 and 2023
measure: Evaluation of body part
timeFrame: Between 2016 and 2023
measure: Evaluation of symptoms
timeFrame: Between 2016 and 2023
measure: Clinical outcome: adverse event
timeFrame: Between 2016 and 2023
measure: Clinical outcome: surgery
timeFrame: Between 2016 and 2023
measure: Clinical outcome: admission to hospital
timeFrame: Between 2016 and 2023
measure: Clinical outcome: mortality
timeFrame: Between 2016 and 2023
measure: Evaluation of age
timeFrame: Between 2016 and 2023
measure: Influence of COVID-19 pandemic
timeFrame: Between 2016 and 2023
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa hospital
Study officials:
References: