US Estimates of Hospitalized Children With Severe Traumatic Brain Injury: Implications for Clinical Trials

Department of Emergency Medicine, University of Michigan, Ann Arbor MI 48105, USA.
PEDIATRICS (Impact Factor: 5.47). 12/2011; 129(1):e24-30. DOI: 10.1542/peds.2011-2074
Source: PubMed


To estimate sample sizes available for clinical trials of severe traumatic brain injury (TBI) in children, we described the patient demographics and hospital characteristics associated with children hospitalized with severe TBI in the United States.
We analyzed the 2006 Kids' Inpatient Database. Severe TBI hospitalizations were defined as children discharged with TBI who required mechanical ventilation or intubation. Types of high-volume severe TBI hospitals were categorized based on the numbers of discharged patients with severe TBI in 2006. National estimates of demographics and hospital characteristics were calculated for pediatric severe TBI. Simulation analyses were performed to assess the potential number of severe TBI cases from randomly selected hospitals for inclusion in future clinical trials.
The majority of children with severe TBI were discharged from either a children's unit in general hospitals (41%) or a nonchildren's hospital (34%). Less than 5% of all hospitals were high-volume TBI hospitals, which discharged >78% of severe TBI cases and were more likely to be a children's unit in a general hospital or a children's hospital. Simulation analyses indicate that there is a saturation point after which the benefit of adding additional recruitment sites decreases significantly.
Children with severe TBI are infrequent at any one hospital in the United States, and few hospitals treat large numbers of children with severe TBI. To effectively plan trials of therapies for severe TBI, much attention has to be paid to selecting the right types of centers to maximize enrollment efficiency.

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Available from: Huiyun Xiang, Mar 23, 2015
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    • "Traumatic Brain Injury (TBI) in children can cause more severe cognitive and behavioral deficits than comparable injuries in mature brains, and is one of the most common reasons for the development of significant lifelong disability in a child (Anderson et al., 2005; Rivara et al., 2012; Stanley et al., 2012; Roozenbeek et al., 2013). This is particularly important if we consider that children under the age of 4 years more frequently undergo TBI than any other age group (Koepsell et al., 2011) and that injured infants under the age of 12 months are at high risk of requiring intensive care support (Keenan et al., 2003). "
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