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Completed

NCT Number: NCT06278376

Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans

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.

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Key information

Age range

6 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa hospital

Hasselt, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • /

Treatment and study plan

Primary outcomes

  1. Incidence

    Time frame: Between 2016 and 2023

    Incidence of diagnostic MRI in childeren

Secondary outcomes

  1. Therapeutical implications: diagnosis

    Time frame: Between 2016 and 2023

    Evaluating the presence of a diagnosis after this MRI investigation

  2. Therapeutical implications: treatment

    Time frame: Between 2016 and 2023

    Evaluating if the MRI investigation resulted in treatment (drug treatment, surgery or physiotherapy)

  3. Clinical indications

    Time frame: Between 2016 and 2023

    Evaluating the clinical indications for the MRI investigation

  4. Evaluation of body part

    Time frame: Between 2016 and 2023

    Evaluating which specific body parts are undergoing imaging

  5. Evaluation of symptoms

    Time frame: Between 2016 and 2023

    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

  6. Clinical outcome: adverse event

    Time frame: Between 2016 and 2023

    Evaluation of the clinical outcome: adverse events

  7. Clinical outcome: surgery

    Time frame: Between 2016 and 2023

    Evaluation of the clinical outcome: surgery after MRI

  8. Clinical outcome: admission to hospital

    Time frame: Between 2016 and 2023

    Evaluation of the clinical outcome: admission to hospital

  9. Clinical outcome: mortality

    Time frame: Between 2016 and 2023

    Evaluation of the clinical outcome: mortality after MRI

  10. Evaluation of age

    Time frame: Between 2016 and 2023

    Evaluation of age in children: <2 years, 2-6 years and >6 years

  11. Influence of COVID-19 pandemic

    Time frame: Between 2016 and 2023

    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

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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