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Study Evaluating Children and Young Adults With Traumatic or Hypoxic-Ischemic Brain Injury Clinical and Neurological Outcomes Over Two Years
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-12
50
Participants Needed
1
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Perinatal asphyxia is a leading cause of severe neurological disabilities and neonatal death, affecting newborns worldwide with varying incidence rates. This condition results in neonatal hypoxic-ischemic encephalopathy, characterized by altered consciousness, seizures, and breathing difficulties in infants born after 35 weeks of gestation. Additionally, traumatic brain injury TBI is a major cause of illness and death in children and young adults, with neuroinflammation playing a key role in both acute and long-term brain damage. Current treatments for these brain injuries are limited, highlighting the urgent need for new therapies with broader therapeutic windows to better protect neurological tissue. The study observes patients aged 0 to 20 years who have brain damage from severe traumatic brain injury or perinatal asphyxia. It evaluates neurological function and disability through clinical assessments, including the Gross Motor Function Classification System. The trial does not involve experimental treatments but focuses on monitoring and assessing participants neurological outcomes over time. Participants undergo evaluations at least two years after their brain injury, including assessments of motor function, muscle tone, disability, quality of life, communication abilities, and overall disability inventory. These evaluations help researchers understand the long-term effects of traumatic and hypoxic-ischemic brain injuries. The study collects data to improve knowledge about these conditions and potential future therapeutic approaches, with the total participation duration extending to two years or more.
CONDITIONS
Brief Title
Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury
Research Team
A
Antonio Chiaretti, Prof
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