Clinical trials for pediatric traumatic brain injury: definition of insanity?

J Neurosurg Pediatr. 2019 Jun 1;23(6):661-669. doi: 10.3171/2019.2.PEDS18384.


Traumatic brain injury (TBI) is a leading cause of morbidity and mortality in children both in the United States and throughout the world. Despite valiant efforts and multiple clinical trials completed over the last few decades, there are no high-level recommendations for pediatric TBI available in current guidelines. In this review, the authors explore key findings from the major pediatric clinical trials in children with TBI that have shaped present-day recommendations and the insights gained from them. The authors also offer a perspective on potential efforts to improve the efficacy of future clinical trials in children following TBI.

Keywords: ABP = arterial blood pressure; CPP = cerebral perfusion pressure; DC = decompressive craniectomy; GCS = Glasgow Coma Scale; GOS = Glasgow Outcome Scale; GOSE = Glasgow Outcome Scale–Extended; GOSE-Peds = GOSE-Pediatric; ICH = intracranial hypertension; ICP = intracranial pressure; MMM = multimodality monitoring; PRx = pressure-reactivity index; PbtO2 = partial pressure of brain oxygenation; RCT = randomized clinical trial; TBI = traumatic brain injury; autoregulation; clinical trials; multimodality monitoring; trauma; traumatic brain injury.

Publication types

  • Review

MeSH terms

  • Brain Injuries, Traumatic* / complications
  • Brain Injuries, Traumatic* / epidemiology
  • Brain Injuries, Traumatic* / therapy
  • Clinical Trials as Topic / methods*
  • Global Health / statistics & numerical data
  • Humans
  • Neurodevelopmental Disorders / epidemiology
  • Neurodevelopmental Disorders / etiology*
  • United States / epidemiology