Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age

Completed

Conditions studied: Adverse Reaction to Drug, Allergic Reaction to Contrast Media

In brief

Our primary outcome is to assess the safety of Dotarem in children \<2 years old up to 24 hours after Dotarem injection. Patients will be monitored for any adverse events that occur for 2 hours following the completion of the MRI exam. The type of event, time of onset, duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not related, probably related, related, definitely related, unclassifiable), and subsequent outcome (required treatment, favorable outcome, recovery with sequela, or death) will be documented. Parents will be given instruction sheets on who and when to call should any adverse event occur after discharge. Parents will be called by the radiology department the next day to identify any adverse events that occurred during the first 24 hours after discharge from the hospital. Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be compared to the combined pre- and post-contrast images following administration of Dotarem by radiologists who are blinded to the patients' clinical information to assess for improvement of image quality and delineation of structures with contrast.

Key facts

Study ID

NCT02609919

Run by

St. Louis University

People needed

150

Starts

2016-01-01

Expected to finish

2019-07-19

Last updated by the study team

2019-09-13

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient under 2 years of age undergoing an MRI exam of the neuraxis or body with or without and with contrast as part of their standard of care.
• Included patients may be scheduled with simultaneous sedation for the MRI.
• Nonsedated patients also qualify for the study.

You may not qualify if…

• Patients 2 years of age or older.
• Patients receiving an MRI exam without contrast.
• Patients with a GFR <30.
• Patients with known renal failure or prior gadolinium based contrast agent hypersensitivity reaction.
• Patients who receive an MRI exam using a different gadolinium-based contrast agent.
• Patients who are not accompanied by a parent will not be included.
• Patients who are unable to complete the MRI exam prior to contrast administration will be excluded.

Where it is running

• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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