Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 20
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients aged 0-20 years diagnosed with brain damage post-severe head trauma or post-perinatal asphyxia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gross Motor Function Classification System
Diagnostic testClinical assessment of the outcome of patients with traumatic and hypoxic-ischemic brain injury at least 2 years post-event.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
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).
Time frame
2 years4
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.
Time frame
2 yearsSecondary outcomes
1
Pediatric Evaluation of Disability Inventory (PEDI)
Two years post-brain injury (traumatic or hypoxic-ischemic), the Pediatric Evaluation of Disability Inventory (PEDI) assesses child's functional abilities in self-care, mobility, and social function, including their reliance on assistive devices like feeding tubes. PEDI provides a detailed profile of the child's abilities across specific domains, rather than a single minimum or maximum score.
Time frame
2 years2
Modified Tardieu Scale
This study clinically evaluates the long-term outcomes (at least two years post-event) of chronic pharmacological therapies for spasticity, measured by the Modified Tardieu Scale (MTS), in patients with traumatic and hypoxic-ischemic brain injury. The MTS differentiates neural (spasticity) from non-neural (contracture) limitations by assessing muscle resistance at varying stretch speeds. This is graded on a scale, typically from 0 to 5, reflecting the intensity of the muscle's reaction to a fast stretch.
Time frame
2 years3
Communication Function Classification System
Two years post-brain injury, this study evaluates everyday communication abilities using the Communication Function Classification System (CFCS). CFCS ranges from Level V (severely limited communication) to Level I (highly effective communication), assessing individuals' ability to exchange information across various settings and with different people.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov