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

Appavu, Brian; Foldes, Stephen T.; Adelson, P. David

doi:10.3171/2019.2.peds18384

Cited by 26 publications

(34 citation statements)

References 56 publications

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“…High-quality research in ICP monitoring and regulation in severe pediatric TBI is still limited. Limitations may be due to the heterogeneity in pathology, patient populations (as previously mentioned), treatment algorithms including threshold values and sensitivity and specificity in outcome measurements (8). Further research must be conducted for future guidelines to provide level I or level II recommendations.…”

Section: Future Perspectivesmentioning

confidence: 99%

“…Further research must be conducted for future guidelines to provide level I or level II recommendations. Studies can still add evidence by examining smaller, but more homogenous patient groups (8), as such studies can also be collected into meta-analysis protocols.…”

Section: Future Perspectivesmentioning

confidence: 99%

“…Where an RCT aims to eliminate as many confounding variables as possible, a high-quality observational study aims to clarify those variables. In the last decades, only ten RCTs in pediatric patients with severe TBI have been conducted and the level of evidence in observational studies is reported as low or moderate (8)(9)(10). This affects both international guidelines for management of severe pediatric TBI and treatment algorithms at individual TBI centers.…”

Section: Introductionmentioning

confidence: 99%

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Monitoring and Measurement of Intracranial Pressure in Pediatric Head Trauma

et al. 2020

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Purpose of Review: Monitoring of intracranial pressure (ICP) is an important and integrated part of the treatment algorithm for children with severe traumatic brain injury (TBI). Guidelines often recommend ICP monitoring with a treatment threshold of 20 mmHg. This focused review discusses; (1) different ICP technologies and how ICP should be monitored in pediatric patients with severe TBI, (2) existing evidence behind guideline recommendations, and (3) how we could move forward to increase knowledge about normal ICP in children to support treatment decisions.

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Section: Future Perspectivesmentioning

confidence: 99%

Section: Future Perspectivesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Monitoring and Measurement of Intracranial Pressure in Pediatric Head Trauma

et al. 2020

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“…The answer lies in the reality of 500 completed, suspended, withdrawn, or terminated clinical trials for traumatic brain injury, of which 127 have been conducted in the pediatric population. As was recently and aptly pointed out by Appavu et al, every trial has failed to produce high-quality evidence for the treatment of pediatric TBI [184]. A common theme across these trials is the targeting of a singular mechanism of secondary injury and use of a small number of biomarkers to evaluate success.…”

Section: Conclusion and Future Directions For Research And Therapymentioning

confidence: 99%

Neuro-Inflammation in Pediatric Traumatic Brain Injury—from Mechanisms to Inflammatory Networks

Fraunberger

Esser

2019

Brain Sciences

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Compared to traumatic brain injury (TBI) in the adult population, pediatric TBI has received less research attention, despite its potential long-term impact on the lives of many children around the world. After numerous clinical trials and preclinical research studies examining various secondary mechanisms of injury, no definitive treatment has been found for pediatric TBIs of any severity. With the advent of high-throughput and high-resolution molecular biology and imaging techniques, inflammation has become an appealing target, due to its mixed effects on outcome, depending on the time point examined. In this review, we outline key mechanisms of inflammation, the contribution and interactions of the peripheral and CNS-based immune cells, and highlight knowledge gaps pertaining to inflammation in pediatric TBI. We also introduce the application of network analysis to leverage growing multivariate and non-linear inflammation data sets with the goal to gain a more comprehensive view of inflammation and develop prognostic and treatment tools in pediatric TBI.

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“…Children sustaining complicated mild TBI have been found to be more vulnerable to developing mild neuropsychological dysfunctions that persist chronically, when compared to adults [ 4 ]. Despite the implications of these findings, both pre-clinical [ 5 ] and clinical [ 6 ] research addressing pediatric TBI is limited. A 2018 systematic review found that despite increasing research, gaps remain in the diagnosis, prognosis, and management of pediatric mild TBI [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

A Novel Clinical Research Modality for Enrolling Diverse Participants Using a Diverse Team

et al. 2020

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The advancement of the pediatric traumatic brain injury (TBI) knowledge base requires biospecimens and data from large samples. This study seeks to describe a novel clinical research modality to establish best practices for enrolling a diverse pediatric TBI population and quantifying key information on enrollment into biobanks. Screening form responses were standardized and cleaned through Google Sheets. Data were used to analyze total individuals at each enrollment stage. R was utilized for final analysis, including logistic model and proportion statistical tests, to determine further significance and relationships. Issues throughout data cleaning shed light on limitations of the consent modality. The results suggest that through a diverse research team, the recruited sample exceeds traditional measures of representation (e.g., sex, race, ethnicity). Sex demographics of the study are representative of the local population. Screening for candidates is critical to the success of the consent modality. The consent modality may be modified to increase the diversity of the study population and accept bilingual candidates. Researchers must implement best practices, including increasing inclusivity of bilingual populations, utilizing technology, and improving participant follow-up, to improve health disparities for understudied clinical populations.

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

Cited by 26 publications

References 56 publications

Monitoring and Measurement of Intracranial Pressure in Pediatric Head Trauma

Monitoring and Measurement of Intracranial Pressure in Pediatric Head Trauma

Neuro-Inflammation in Pediatric Traumatic Brain Injury—from Mechanisms to Inflammatory Networks

A Novel Clinical Research Modality for Enrolling Diverse Participants Using a Diverse Team

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