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

NCT02609919 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Adverse Reaction to Drug
  • Allergic Reaction to Contrast Media

Interventions

DRUG

Gadoteric Acid

MRI Contrast Agent

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Shannon Farmakis, MD · St. Louis University School of Medicine

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-07-18
Completion
2019-07-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609919 on ClinicalTrials.gov