Rectal Ozone as Neuroprotector Post CNS Insult in Children

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

Study Overview

• Status: Recruiting
• Conditions: Children; CNS; Rectal Ozone; Neuroprotector; Insult
• Intervention / Treatment: Other: Rectal ozone sessions; Other: Conventional rehabilitation program

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Asfour, Master; Phone Number: 00201017440223; Email: drahmedasfour14@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Recruiting
    • Al-Azhar University
    • Sub-Investigator: Abeer M Salamah, MD
    • Contact: Ahmed M Asfour, Master; Phone Number: 00201017440223; Email: drahmedasfour14@gmail.com
    • Sub-Investigator: Osama A Elagami, MD
    • Sub-Investigator: Mohamed I Hussein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.	Other: Rectal ozone sessions; Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
Active Comparator: Group 2; Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).	Other: Conventional rehabilitation program; Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of reduction in neuroinflammation	Incidence of reduction in neuroinflammation will be recorded.	6 months post-sessions
Assessment of quality of life	Assessment of quality of life including emotional well-being or social interaction will be recorded.	6 months post-sessions
Incidence of adverse effects	Incidence of adverse effects will be recorded.	6 months post-sessions
Measurement of age-related response variability	Age-related response variability by evaluating how different age groups respond to treatment will be recorded.	6 months post-sessions

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: August 30, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KFSIRB200-623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No