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

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ClinicalTrials.gov Identifier: NCT03561168

Recruitment Status : Completed

First Posted : June 19, 2018

Last Update Posted : June 19, 2018

Sponsor:

Information provided by (Responsible Party):

Jamie Sinton, Baylor College of Medicine

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
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

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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 :	October 12, 2017
Actual Primary Completion Date :	June 15, 2018
Actual Study Completion Date :	June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Genetic and Rare Diseases Information Center resources: Neurotoxicity Syndromes

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	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.

Outcome Measures

Primary Outcome Measures :

Etiologic diagnosis obtained from MRI brain [ Time Frame: 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 [ Time Frame: 1 year ]
To determine the doses of all anesthetic and sedative agents administered and the duration of anesthesia
Incidence of repeat MRI [ Time Frame: 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

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Ages Eligible for Study:	up to 1095 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561168

Locations

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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

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Study Director:	Dean B Andropoulos, MD	Baylor College of Medicine
Principal Investigator:	Jamie W Sinton, MD	Baylor College of Medicine

More Information

Publications:

Murias K, Moir A, Myers KA, Liu I, Wei XC. Systematic review of MRI findings in children with developmental delay or cognitive impairment. Brain Dev. 2017 Sep;39(8):644-655. doi: 10.1016/j.braindev.2017.04.006. Epub 2017 Apr 27. Review.

Simpson GA, Colpe L, Greenspan S. Measuring functional developmental delay in infants and young children: prevalence rates from the NHIS-D. Paediatr Perinat Epidemiol. 2003 Jan;17(1):68-80.

Rodriguez DP, Poussaint TY. Neuroimaging of the child with developmental delay. Top Magn Reson Imaging. 2007 Feb;18(1):75-92. Review.

Decobert F, Grabar S, Merzoug V, Kalifa G, Ponsot G, Adamsbaum C, des Portes V. Unexplained mental retardation: is brain MRI useful? Pediatr Radiol. 2005 Jun;35(6):587-96. Epub 2005 Mar 1.

Schaefer GB, Bodensteiner JB. Radiological findings in developmental delay. Semin Pediatr Neurol. 1998 Mar;5(1):33-8. Review.

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.

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Responsible Party:	Jamie Sinton, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT03561168
Other Study ID Numbers:	H-41288
First Posted:	June 19, 2018 Key Record Dates
Last Update Posted:	June 19, 2018
Last Verified:	June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	This is a retrospective study, this question seems not applicable.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Jamie Sinton, Baylor College of Medicine:


Pediatric MRI Indications Anesthesia Anesthetic Neurotoxicity MRI Diagnostic Yield

Additional relevant MeSH terms:

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Seizures Neurotoxicity Syndromes Neurologic Manifestations	Nervous System Diseases Poisoning Chemically-Induced Disorders

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