Al-Azhar University
Cairo, 11651, Egypt
Location status: Recruiting
Location contact
Abeer M Salamah, MD
SUB_INVESTIGATOR
Ahmed M Asfour, Master
CONTACT
Mohamed I Hussein, MD
SUB_INVESTIGATOR
Osama A Elagami, MD
SUB_INVESTIGATOR
NCT Number: NCT07153627
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Interested in participating?
Request Info1 month–18 year
All sexes
Interventional
Not applicable
Cairo, 11651, Egypt
Location status: Recruiting
Abeer M Salamah, MD
SUB_INVESTIGATOR
Ahmed M Asfour, Master
CONTACT
Mohamed I Hussein, MD
SUB_INVESTIGATOR
Osama A Elagami, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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.
Time frame: 6 months post-sessions
Incidence of reduction in neuroinflammation will be recorded.
Time frame: 6 months post-sessions
Assessment of quality of life including emotional well-being or social interaction will be recorded.
Time frame: 6 months post-sessions
Incidence of adverse effects will be recorded.
Time frame: 6 months post-sessions
Age-related response variability by evaluating how different age groups respond to treatment will be recorded.
Contact information is provided by the study sponsor or research team.
Al-Azhar University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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