Rectal ozone to protect children's brains after acquired brain injury
Official title: Rectal Ozone as Neuroprotector Post CNS Insult in Children
Run by Al-Azhar University · NCT07153627 · Data updated 2026-11-12
This study will try rectal ozone to see if it protects the brains of children who have had an acquired brain injury.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | September 4, 2025 |
| Trial ID | NCT07153627 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 1 month to 18 years admitted to the PICU with MRI-confirmed acquired brain injury and resulting neurological sequelae who are medically fit for rectal ozone are ideal candidates.
✕Probably not a fit
Children without neurological deficits, those with active or recurrent seizures, significant behavioral problems, a relevant family history of degenerative brain disease, or who are not medically fit for rectal ozone are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will give pediatric patients admitted with acquired brain injury rectal ozone therapy sessions alongside a conventional rehabilitation program and monitor outcomes. Eligible children are 1 month to 18 years old with neurological sequelae confirmed by examination and MRI while admitted to the PICU. Key exclusions include active or recurrent seizures, behavioral problems, a family history of degenerative brain disease, or being unfit for rectal ozone. The trial is conducted at Al-Azhar University in Cairo and will track clinical and imaging measures for signs of neuroprotection.
Why it matters
Potential benefit: If successful, rectal ozone could reduce brain damage and improve neurological recovery and functional outcomes in affected children.
How similar studies have gone: Use of ozone for neuroprotection in children is largely novel with limited supporting evidence and mixed results from small adult or preclinical studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Al-Azhar University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed M Asfour, Master
- Email: drahmedasfour14@gmail.com
- Phone: 00201017440223
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.