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

Completed

• Conditions: Seizures; Development Delay; Anesthetic Neurotoxicity
• Interventions: Diagnostic Test: Change in plan of care based on MRI results

• Registration Number: NCT03561168
• Lead Sponsor: Baylor College of Medicine

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 Timeline

• Study Start: 2017-10-12
• Status Verified: 2018-06
• Study First Submitted: 2018-06-07
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Study First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Developmental Delay	Change in plan of care based on MRI results	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.
Seizure	Change in plan of care based on MRI results	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.
Developmental Delay and Seizure	Change in plan of care based on MRI results	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.

Primary Outcome Measures

Name	Time	Method
Etiologic diagnosis obtained from MRI brain	1 year	Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.

Secondary Outcome Measures

Name	Time	Method
Quantify anesthetic exposure	1 year	To determine the doses of all anesthetic and sedative agents administered and the duration of anesthesia
Incidence of repeat MRI	1 year	To determine the incidence of repeat MRI scan in the study population. anesthesia. To determine the incidence of repeat MRI scan in the study population.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States