Actively Recruiting

Age: 0 - 20Years
All Genders
ID06873477

Clinical and Epidemiological Evaluation of Patients With Traumatic and Hypoxic-ischemic Brain Injury

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-12

50

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

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

Who Can Participate

Age: 0 - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 0 to 20 years with brain damage due to severe traumatic brain injury or perinatal asphyxia seen at the Pediatric Emergency Department
  • Signed informed consent by the patient, parent, or legal guardian
  • Adult patients with cognitive impairments may participate with consent from a legal guardian
Not Eligible

You will not qualify if you...

  • Refusal to sign informed consent
  • Presence of congenital malformations or genetic syndromes
  • Diagnosis of neuromuscular diseases
  • Encephalopathies caused by conditions other than severe head trauma or asphyxia
  • Significant congenital heart diseases affecting hemodynamics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At least 2 years post-event

Participants undergo clinical assessments using the Gross Motor Function Classification System and other scales to evaluate outcomes after brain injury.

1 to 2 visits depending on assessment schedules

Long-term Monitoring

Duration - Up to 2 years

Participants are observed over time to monitor neurological function and quality of life following brain injury.

Periodic follow-up visits during the monitoring period

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS, Pronto Soccorso Pediatrico

Rome, Lazio, Italy, 00168

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Research Team

A

Antonio Chiaretti, Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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