Michigan — Targeted Issue

Progesterone for Traumatic Brain Injury in Children: Planning a Safety and Efficacy Trial

Sept. 1, 2010 - Aug. 31, 2013

Grant Number
Project Overview
Traumatic brain injury (TBI) is a leading cause of morbidity from trauma and of death in children. Despite decades of research, no effective treatment exists for children with TBI. The objective of this project is to plan a safety and efficacy trial of progesterone for TBI in children. The goals of this project are to (1) coordinate and organize an executive planning committee that will prepare the protocol for a safety and efficacy trial of progesterone for children with TBI, including detailed inclusion/exclusion criteria and study outcomes; (2) pilot the inclusion/exclusion criteria in a prospective feasibility study in the participating centers in PECARN; and (3) hold a meeting with ED and neurocritical care investigators from each site to discuss standardization of care (other than the study intervention), refine ideas, and come to a consensus on key elements of the protocol.
University of Michigan, Ann Arbor
Main Contact
Award Amount


Name Role(s) Phone Email
Rachel Stanley, MD, MHSA
  • Principal Investigator
(614) 722-4385 rachel.stanley@nationwidechildrens.org


Title Type Publication/Event Published/Presented Identifier Details
Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study Research Paper/Publication Academic Emergency Medicine 2017
Progesterone for Neuroprotection in Pediatric Traumatic Brain Injury Research Paper/Publication Pediatric Critical Care Medicine 2015
Sex differences in the effect of progesterone after controlled cortical impact in adolescent mice: a preliminary study Research Paper/Publication Journal of Neurosurgery 2014
Acute evaluation of pediatric patients with minor traumatic brain injury Research Paper/Publication Current Opinion in Pediatrics 2012