Rectal Ozone as Neuroprotector Post CNS Insult in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorAl-Azhar University
About this trial
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rectal ozone sessions
Other interventionPatients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
Conventional rehabilitation program
Other interventionPatients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Group IExperimental treatment 1 intervention
Group B: Group 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of muscle Tone
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.
Time frame
6 months post-sessionsSecondary outcomes
1
Incidence of reduction in neuroinflammation
Incidence of reduction in neuroinflammation will be recorded.
Time frame
6 months post-sessions2
Assessment of quality of life
Assessment of quality of life including emotional well-being or social interaction will be recorded.
Time frame
6 months post-sessions3
Incidence of adverse effects
Incidence of adverse effects will be recorded.
Time frame
6 months post-sessions4
Measurement of age-related response variability
Age-related response variability by evaluating how different age groups respond to treatment will be recorded.
Time frame
6 months post-sessionsSponsors and contacts
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Source ClinicalTrials.gov