Rectal Ozone as Neuroprotector Post CNS Insult in Children

NCT ID: NCT07153627

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-10-01

Brief Summary

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.

Conditions

Rectal Ozone; Neuroprotector; CNS; Insult; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.

Group Type: EXPERIMENTAL

Rectal ozone sessions

Intervention Type: OTHER

Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.

Group 2

Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation program

Intervention Type: OTHER

Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).

Interventions

Rectal ozone sessions

Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.

Intervention Type: OTHER

Conventional rehabilitation program

Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abd ELgawad Mohamed Asfour

Assistant Lecturer of Pediatrics, Faculty of Medicine, Al-Azhar University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Azhar University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed M Asfour, Master

Role: CONTACT

drahmedasfour14@gmail.com

00201017440223

Facility Contacts

Ahmed M Asfour, Master

Role: primary

drahmedasfour14@gmail.com

00201017440223

Other Identifiers

KFSIRB200-623

Identifier Type: -

Identifier Source: org_study_id