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

Baylor College of Medicine

Status: Completed

Conditions: Seizures; Development Delay; Anesthetic Neurotoxicity

Treatments: Diagnostic Test: Change in plan of care based on MRI results

Study type: Observational

Funder types: Other

Identifiers

NCT03561168

H-41288

Details and patient eligibility

About

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.

Full 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.

Enrollment: 561 patients

Sex: All

Ages: Under 1095 days old

Volunteers: No Healthy Volunteers

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.

Trial design

561 participants in 3 patient groups

Developmental Delay

Description:

Children under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution.

Treatment:

Diagnostic Test: Change in plan of care based on MRI results

Seizure

Description:

Children under age 3 who underwent MRI brain with anesthesia for the indication of Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution.

Treatment:

Diagnostic Test: Change in plan of care based on MRI results

Developmental Delay and Seizure

Description:

Children under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay and Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution.

Treatment:

Diagnostic Test: Change in plan of care based on MRI results