Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT03561168
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Review of Diagnostic Yield of MRI Brain Results in Children Under Age 3 Years
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday.
Detailed Description:
On December 14, 2016 the FDA issued a warning regarding elective anesthetics in children under three years of age. While a single, short exposure to general anesthesia may not have negative effects on behavior or learning, repeated or prolonged anesthetics may affect brain development. To that end, minimizing exposure to elective general anesthetics if procedures are not clearly indicated in young children appeals to reason.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: