Prevention of complications related to traumatic brain injury in children and adolescents with creatine administration: An open label randomized pilot study

Background. There has been an enormous focus on the discovery and development of neuroprotective agents that might have clinical relevance after traumatic brain injury (TBI). Based on experimental facts, we studied administration of creatine to patients with TBI. Methods. A prospective, randomized, comparative, open-labeled pilot study of the possible neuroprotective effect of creatine was performed on 39 children and adolescents, aged between 1 to 18 years old, with TBI. The creatine was administered for 6 months, at a dose of 0.4 gr/kg in an oral suspension form every day. For categorical variables, we used the chi(2) test to identify differences between controls and cases. Statistical significance was defined as a p value < 0.05 and not statistically significant if p value > 0.1. Results. The administration of creatine to children with TBI improved results in several parameters, including duration of post-traumatic amnesia (PTA), duration of intubation, intensive care unit (ICU) stay, disability, good recovery, self care, communication, locomotion, sociability, personality/behavior and neurophysical, and cognitive function. Significant improvement was recorded in the categories of Cognitive (p < 0.001), personatity/behavior (p < 0.001), Self Care (p = 0.029), and communication (p = 0.018) aspects in all patients. No side effects were seen because of creatine administration. Conclusion. Preliminary data suggest that the administration of creatine may be beneficial to patients with traumatic brain injury.