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

Seizures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561168
• Other study ID #: H-41288
• Status: Completed
• Start date: October 12, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2018
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1095 Days

Eligibility

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.

Related Conditions & MeSH terms

• Anesthetic Neurotoxicity
• Development Delay
• Neurotoxicity Syndromes
• Seizures

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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] — View 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. — View Citation

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

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

Outcome

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