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NCT02609919 · ClinicalTrials.gov registry record
Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age
A clinical trial of Adverse Reaction to Drug and Allergic Reaction to Contrast Media, sponsored by St. Louis University.
- Completed
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT02609919 is a study of Adverse Reaction to Drug and Allergic Reaction to Contrast Media that has completed, run by St. Louis University. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02609919, a study of Adverse Reaction to Drug and Allergic Reaction to Contrast Media, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Gadoteric Acid
Study Locations (1)
Missouri
- Saint Louis University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-07-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02609919
The ClinicalTrials.gov registry entry for NCT02609919 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Adverse Reaction to Drug appearing as the primary indexed condition, and to 1 intervention - of which Gadoteric Acid is the first listed.
NCT02609919 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT02609919 about?
NCT02609919 is a clinical study titled "Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age". 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, intensit...
What is the current status of trial NCT02609919?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2016-01. Estimated completion is 2019-07-19.
What conditions does trial NCT02609919 study?
This clinical trial studies the following conditions: Adverse Reaction to Drug, Allergic Reaction to Contrast Media.
What interventions are being tested in trial NCT02609919?
The interventions under investigation include: Gadoteric Acid (DRUG).
Who is sponsoring clinical trial NCT02609919?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02609919 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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