Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

H-41288


NCT ID:

NCT03561168


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

1095 Days


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor College of Medicine


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

561


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dean B Andropoulos, MD
Study Director
Baylor College of Medicine

Study Dates

Start Date:October 12, 2017
Completion Date:June 15, 2018
Completion Type:Actual
Primary Completion Date:June 15, 2018
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 18, 2018
First Received Date:June 7, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of repeat MRI
Time Frame:1 year
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Quantify anesthetic exposure
Time Frame:1 year
Safety Issues:False
Description:To determine the doses of all anesthetic and sedative agents administered and the duration of anesthesia
Outcome Type:Primary Outcome
Measure:Etiologic diagnosis obtained from MRI brain
Time Frame:1 year
Safety Issues:False
Description:Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.

Study Interventions

Intervention Type:Diagnostic Test
Name:Change in plan of care based on MRI results
Description: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 Name:Developmental Delay

Study Arms

Study Arm Type:Other
Arm Name:Developmental Delay
Description: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.
Study Arm Type:Other
Arm Name:Seizure
Description: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.
Study Arm Type:Other
Arm Name:Developmental Delay and Seizure
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine

Samples and Retentions

Study Population: Children under age 3 undergoing MRI brain with anesthesia or sedation between Dec 13, 2015 and Dec 13, 2016
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
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 Aug 25. [Epub ahead of print]
PMID:27564559
Reference Type:Reference
Citation:Schaefer GB, Bodensteiner JB. Radiological findings in developmental delay. Semin Pediatr Neurol. 1998 Mar;5(1):33-8. Review.
PMID:9548639
Reference Type:Reference
Citation: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.
PMID:15739114
Reference Type:Reference
Citation:Rodriguez DP, Poussaint TY. Neuroimaging of the child with developmental delay. Top Magn Reson Imaging. 2007 Feb;18(1):75-92. Review.
PMID:17607144
Reference Type:Reference
Citation: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.
PMID:12562474
Reference Type:Reference
Citation: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.
PMID:28457518

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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