NCT03561168

Review of Diagnostic Yield of MRI Brain Results in Children Under Age 3 Years

Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 561 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 1095 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Seizures
• Development Delay
• Anesthetic Neurotoxicity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Change in plan of care based on MRI results	Study subjects have "received the intervention" if the results of their MRI either 1. provide an etiology for said MRI's indication or 2. the patient received a change in plan of care based on MRI results.

Timeline

• Start date: 2017-10-12
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2018-06-19
• Last updated: 2018-06-19

Locations

1 site across 1 country: United States