Clinical trial NCT03561168: Review of Diagnostic Yield of MRI Brain Results in Children Under Age 3 Years
Official title: Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Development Delay
Anesthetic Neurotoxicity
Keywords: Pediatric
MRI Indications
Anesthesia
Anesthetic Neurotoxicity
MRI Diagnostic Yield
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 561
Sex: ALL
Maximum age (years): 1095
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under age 3 undergoing MRI brain with anesthesia or sedation between Dec 13, 2015 and Dec 13, 2016

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.

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.

Primary outcomes:
measure: Etiologic diagnosis obtained from MRI brain
timeFrame: 1 year
Secondary outcomes:
measure: Quantify anesthetic exposure
timeFrame: 1 year
measure: Incidence of repeat MRI
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dean B Andropoulos, MD
role: STUDY_DIRECTOR
affiliation: Baylor College of Medicine
name: Jamie W Sinton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Huang YY, Li L, Monteleone M, Ferrari L, States LJ, Riviello JJ, Kernie SG, Mencin AA, Gupta S, Sun LS. Use of Anesthesia for Imaging Studies and Interventional Procedures in Children. J Neurosurg Anesthesiol. 2016 Oct;28(4):400-404. doi: 10.1097/ANA.0000000000000355.