Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 6, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying new treatment options for children and young adults who have suffered from severe brain injuries, specifically due to traumatic brain injury or a condition called perinatal asphyxia, which occurs when a baby does not get enough oxygen at birth. These conditions can lead to serious health issues, including difficulties with breathing, seizures, and long-term disabilities. The researchers hope to find better ways to protect the brain and improve recovery since current treatments, like therapeutic hypothermia, are only partially effective.
To participate in the trial, eligible patients must be between the ages of 0 and 20 and have experienced significant brain damage from either severe head trauma or perinatal asphyxia. Parents or guardians will need to provide consent for younger patients, while older patients may also be asked to give their consent if they are able. Participants will be closely monitored throughout the study to assess the effectiveness of the new treatments being tested. This trial is currently recruiting, and it aims to offer hope for improved outcomes in managing brain injuries in young patients.
Gender
ALL
Eligibility 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
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, Lazio, Italy
Patients applied
Trial Officials
Antonio Chiaretti
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported