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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03561168
Enrollment
561
Registered
2018-06-19
Start date
2017-10-12
Completion date
2018-06-15
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetic Neurotoxicity, Development Delay, Seizures

Keywords

Pediatric, MRI Indications, Anesthesia, Anesthetic Neurotoxicity, MRI Diagnostic Yield

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.

Interventions

DIAGNOSTIC_TESTChange 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.

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1095 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Etiologic diagnosis obtained from MRI brain1 yearDetermine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.

Secondary

MeasureTime frameDescription
Quantify anesthetic exposure1 yearTo determine the doses of all anesthetic and sedative agents administered and the duration of anesthesia
Incidence of repeat MRI1 yearTo determine the incidence of repeat MRI scan in the study population. anesthesia. To determine the incidence of repeat MRI scan in the study population.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026