Rectal Ozone, Neuroprotector, CNS, Insult, Children
Conditions
Brief summary
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Detailed description
Acquired brain injury (ABI) from primary neurologic diagnoses accounts for 20% of all pediatric critical care admissions and more than 60,000 hospital admissions annually. Ozone (O3) gas was discovered in the 1840s, and soon after that, the scientific community began to expand past the notion that it was just another gas of the Earth's atmosphere.
Interventions
OTHERRectal ozone sessions
Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age from 1 month to 18 years. * Both sexes. * Children admitted to the pediatric intensive care unit (PICU) with acquired neurological insult. * Children with neurological sequelae * Children who are exposed to acquired brain injury, e.g., traumatic brain injury, cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, or hypoxia, with neurological sequelae diagnosed by neurological examination and magnetic resonance imaging (MRI), to detect that disorder early.
Exclusion criteria
* Patients with no degree of disability or sequelae. * Patients not fit for Rectal ozone therapy. * Patients with active epilepsy and recurrent seizures. * Children with a positive family history of degenerative brain insults. * Children with behavioral problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of muscle Tone | 6 months post-sessions | Assessment of muscle tone (degree of spasticity) of affected child according to Modified Ashworth's Scale. Ashworth's scale is a 6-point scale, from 0 to 4, with higher scores indicating greater spasticity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of reduction in neuroinflammation | 6 months post-sessions | Incidence of reduction in neuroinflammation will be recorded. |
| Assessment of quality of life | 6 months post-sessions | Assessment of quality of life including emotional well-being or social interaction will be recorded. |
| Incidence of adverse effects | 6 months post-sessions | Incidence of adverse effects will be recorded. |
| Measurement of age-related response variability | 6 months post-sessions | Age-related response variability by evaluating how different age groups respond to treatment will be recorded. |
Countries
Egypt
Contacts
Primary ContactAhmed M Asfour, Master
Outcome results
None listed