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Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses

Natale J.E.a · Joseph J.G.b · Pretzlaff R.K.a · Silber T.J.c · Guerguerian A.-M.d
aCritical Care Medicine, Department of Pediatrics, bDepartment of Pediatrics and Office of the Dean, UC Davis School of Medicine, Sacramento, Calif., and cGeneral Clinical Research Center, Children’s National Medical Center, Washington, D.C., USA; dDepartment of Critical Care Medicine, Hospital for Sick Children, Toronto, Canada Dev Neurosci 2006;28:276–290 (DOI:10.1159/000094154)

Abstract

In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.

 

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