Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury

NCT06873477 | Recruiting

• 1 other identifier: 7043
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 incidence of 3.94-5.12 per 1,000 live births. Perinatal asphyxia leads to neonatal hypoxic-ischemic encephalopathy, which remains a common cause of neonatal death and long-term disabilities, affecting 1.5-3 per 1,000 live births in developed countries and up to 26 per 1,000 live births in developing countries. This condition is characterized by altered levels of consciousness or manifests with seizures, often associated with difficulties in initiating and maintaining breathing, as well as depression of tone and reflexes. Currently, therapeutic hypothermia is the standard treatment for neonates with moderate to severe hypoxic-ischemic encephalopathy; however, it does not provide complete neuroprotection and is only partially effective. Therefore, new treatments with good therapeutic windows are urgently needed to ensure the best possible preservation of neurological tissue for patients exposed to hypoxic-ischemic insult. Traumatic brain injury is a common cause of morbidity and mortality among children and young adults in developed countries. The incidence of traumatic brain injury has increased in recent years, yet the prognosis for these patients has not substantially changed. In recent studies the key intermediary role of the immune system and neuroinflammation has been proposed to explain the pathophysiology of traumatic brain injury, both in the acute phase and in the long term. Indeed, neuroinflammatory processes can persist for several months, contributing to chronic alterations and accelerating brain aging in patients with post-traumatic brain injury. Currently, therapies that have shown promising results in patients with post-traumatic brain injuries are unfortunately still limited, especially in the context of severe traumatic brain injury. Thus, there is an urgent need for new treatments with a broader therapeutic window that can counteract early and chronic pathophysiological events.

Conditions

Brain Injuries; Brain Ischemia

Outcome Measures

Primary Outcomes (4)

• Gross Motor Function Classification System

  Clinical assessment of the outcome of patients with traumatic and hypoxic-ischemic brain injury at least 2 years post-event, in terms of Analysis of motor deficits using the standardized scale "Gross Motor Function Classification System" where applicable. GMFCS is composed of 5 levels. Level I: Walks without limitations. Level V: Transported in a manual wheelchair.

  2 years

• Modified Ashworth Scale

  Clinical assessment of the outcome of patients with traumatic and hypoxic-ischemic brain injury at least 2 years post-event, in terms of Analysis of variations in muscle hypertonia and spasticity since the clinical event using the standardized scale "Modified Ashworth Scale" where applicable. Minimum Value: 0 This indicates no increase in muscle tone. Maximum Value: 4 This indicates that the affected part is rigid in flexion or extension.

  2 years

• Disability Rating Scale (DRS)

  Clinical assessment of the outcome of patients with traumatic and hypoxic-ischemic brain injury at least 2 years post-event, in terms of Analysis of the degree of disability using the standardized scale "Disability Rating Scale (DRS)" where applicable. Minimum value: 0 (indicates no disability). Maximum value: 30 (indicates an extreme vegetative state).

  2 years

• Pediatric Quality of Life Inventory generic core scale

  Clinical assessment of the outcome of patients with traumatic and hypoxic-ischemic brain injury at least 2 years post-event, in terms of Analysis of quality of life through administration of the standardized scale "Pediatric Quality of Life Inventory generic core scale" to the patient and caregiver where applicable. The minimum possible score is 0. The maximum possible score is 100. Higher scores indicate a better health-related quality of life.

  2 years

Secondary Outcomes (3)

• Pediatric Evaluation of Disability Inventory (PEDI)

  2 years

• Modified Tardieu Scale

  2 years

• Communication Function Classification System

  2 years

Interventions

Gross Motor Function Classification System DIAGNOSTIC_TEST

Clinical assessment of the outcome of patients with traumatic and hypoxic-ischemic brain injury at least 2 years post-event.

Also known as: Modified Ashworth Scale, Disability Rating Scale (DRS), Pediatric Quality of Life Inventory generic core scale

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients aged 0-20 years diagnosed with brain damage post-severe head trauma or post-perinatal asphyxia.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, Pronto Soccorso Pediatrico

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Brain Ischemia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antonio Chiaretti

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Chiaretti, Prof

CONTACT

+390630155940; antonio.chiaretti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: March 12, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-01

Locations

IT (1)