Evaluation of patients with traumatic and hypoxic-ischemic brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.