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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03561168

Collaborator

(none)

561

Enrollment

Location

8.1

Actual Duration (Months)

69.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seizures Development Delay Anesthetic Neurotoxicity	Diagnostic Test: Change in plan of care based on MRI results

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 Design

Study Type:

Observational

Actual Enrollment :

561 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 12, 2017

Actual Primary Completion Date :

Jun 15, 2018

Actual Study Completion Date :

Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Developmental Delay 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.	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.
Seizure 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.	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.
Developmental Delay and Seizure 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.	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.

Arm

Intervention/Treatment

Developmental Delay

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.

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.

Seizure

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.

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

Developmental Delay and Seizure

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.

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1095 Days

Sexes Eligible for Study:

All

Accepts 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.