Rectal Ozone as Neuroprotector Post CNS Insult in Children

NCT07153627 | Recruiting

• 1 other identifier: KFSIRB200-623
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.

Conditions

Rectal Ozone; Neuroprotector; CNS; Insult; Children

Outcome Measures

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.

  6 months post-sessions

Secondary Outcomes (4)

• Incidence of reduction in neuroinflammation

  6 months post-sessions

• Assessment of quality of life

  6 months post-sessions

• Incidence of adverse effects

  6 months post-sessions

• Measurement of age-related response variability

  6 months post-sessions

Study Arms (2)

Group I

EXPERIMENTAL

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

Other: Rectal ozone sessions

Group 2

ACTIVE COMPARATOR

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

Other: Conventional rehabilitation program

Interventions

Rectal ozone sessions OTHER

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

Group I

Conventional rehabilitation program OTHER

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

Group 2

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

RECRUITING

Central Study Contacts

Ahmed M Asfour, Master

CONTACT

00201017440223; drahmedasfour14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatrics, Faculty of Medicine, Al-Azhar University, Egypt.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 4, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)