Assessment of Immediate Adverse Reactions in Children Under 2 Years of Age Following Administration of Gadoteric Acid (Gd-DOTA or Dotarem)

Our primary outcome is to assess the safety of Dotarem in these patients up to 24 hours after Dotarem injection. The patients will be monitored in the hospital for at least 2 hours following the completion of the MRI exam. Many of these patients will have received sedation for the MRI and would be monitored normally for up to 1 hour after the exam is completed. Patients will be monitored for any adverse events that occurred during the observation period. 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 an information sheet prior to discharge indicating the possible adverse events that may occur related to the administration of Dotarem with instructions on what to do and who to call, if necessary, should any of them occur. 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.

200 patients are expected to be enrolled in this study over the course of 18 months.

Exclusion criteria: 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.

Inclusion criteria: Any patient under 2 years of age undergoing an MRI exam of the neuraxis or body with and without 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.