Evaluation of patients with traumatic and hypoxic-ischemic brain injuries
Clinical and Epidemiological Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury
This study is trying to understand how brain injuries from trauma or lack of oxygen affect kids and young adults under 20, to find better ways to help them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | N/A to 20 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06873477 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients aged 0-20 years who have experienced brain damage due to severe traumatic brain injury or perinatal asphyxia. It aims to evaluate the neurological function disturbances associated with neonatal hypoxic-ischemic encephalopathy, a condition that can lead to significant long-term disabilities. The study will involve assessments at the Pediatric Emergency Department, where informed consent will be obtained from parents or legal guardians. The research seeks to better understand the complexities of brain injuries in this vulnerable population and explore potential new treatment avenues.
Who should consider this trial
Good fit: Ideal candidates include patients aged 0-20 years with brain damage from severe traumatic brain injury or perinatal asphyxia.
Not a fit: Patients with congenital malformations, genetic syndromes, neuromuscular diseases, or encephalopathies from other causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for infants and children suffering from severe brain injuries.
How similar studies have performed: While therapeutic hypothermia is currently the standard treatment, this study explores new approaches, indicating a need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Universitario A. Gemelli IRCCS, Pronto Soccorso Pediatrico — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Antonio Chiaretti — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Antonio Chiaretti, Prof
- Email: antonio.chiaretti@policlinicogemelli.it
- Phone: +390630155940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.