Status:
RECRUITING
Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Brain Injuries
Brain Ischemia
Eligibility:
All Genders
Up to 20 years
Brief Summary
According to the World Health Organization, perinatal asphyxia is the leading cause of severe neurological disabilities and the second leading cause of neonatal death among term infants, with an incid...
Detailed Description
According to the World Health Organization, perinatal asphyxia is the leading cause of severe neurological disabilities and the second leading cause of neonatal death among term infants, with an incid...
Eligibility Criteria
Inclusion
- Patients aged 0-20 years with brain damage due to severe traumatic brain injury or perinatal asphyxia evaluated at the Pediatric Emergency Department
- Informed consent signed by the parents, the adult patient, or the legal guardian/representative.
- Adult patients with psycho-cognitive impairments that affect their ability to provide consent, with prior acquisition of informed consent from the guardian/legal representative.
Exclusion
- Refusal to sign the informed consent
- Patients with congenital malformations or genetic syndromes
- Patients with neuromuscular diseases
- Patients with encephalopathies of etiology other than severe head trauma or asphyxia
- Patients with hemodynamically significant congenital heart diseases
Key Trial Info
Start Date :
January 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06873477
Start Date
January 15 2025
End Date
July 31 2027
Last Update
March 12 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, Pronto Soccorso Pediatrico
Rome, Lazio, Italy, 00168