Skip to main content
Clinical Trials/NCT03561168
NCT03561168
Completed
Not Applicable

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

Baylor College of Medicine1 site in 1 country561 target enrollmentOctober 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Seizures
Sponsor
Baylor College of Medicine
Enrollment
561
Locations
1
Primary Endpoint
Etiologic diagnosis obtained from MRI brain
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2017
End Date
June 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jamie Sinton

Assistant Professor

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Male or female aged 0-36 months who received anesthesia (volatile gas anesthesia) or IV sedation (propofol, dexmedetomidine, barbiturates, benzodiazepines, or other agents) for brain MRI

Exclusion Criteria

  • MRI without sedation, brain MRI plus additional MRI imaging, i.e. spine, heart, etc., sedated MRI by a member of other department besides Anesthesiology.

Outcomes

Primary Outcomes

Etiologic diagnosis obtained from MRI brain

Time Frame: 1 year

Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.

Secondary Outcomes

  • Incidence of repeat MRI(1 year)
  • Quantify anesthetic exposure(1 year)

Study Sites (1)

Loading locations...

Similar Trials