Rectal Ozone as Neuroprotector Post CNS Insult in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rectal ozone sessions, Conventional rehabilitation program.
- Who it may be relevant to
- Registry conditions: Rectal Ozone, Neuroprotector, CNS, Insult. Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Rectal ozone sessions
Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program. - Other Conventional rehabilitation program
Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
Primary outcome measures
- Assessment of muscle Tone [Time frame: 6 months post-sessions]
Secondary outcome measures (4)
- Incidence of reduction in neuroinflammation [Time frame: 6 months post-sessions]
- Assessment of quality of life [Time frame: 6 months post-sessions]
- Incidence of adverse effects [Time frame: 6 months post-sessions]
- Measurement of age-related response variability [Time frame: 6 months post-sessions]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Al-Azhar University — Cairo
Identifiers
NCT: NCT07153627 · KFSIRB200-623