Rectal ozone to protect children's brains after acquired brain injury
Rectal Ozone as Neuroprotector Post CNS Insult in Children
This study will try rectal ozone to see if it protects the brains of children who have had an acquired brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07153627 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Use of ozone for neuroprotection in children is largely novel with limited supporting evidence and mixed results from small adult or preclinical studies.
Eligibility criteria
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 this trial is running
Cairo
- Al-Azhar University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed M Asfour, Master
- Email: drahmedasfour14@gmail.com
- Phone: 00201017440223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.