Rectal Ozone as Neuroprotector Post CNS Insult in Children

Al-Azhar University

Status: Enrolling

Conditions: Insult; Neuroprotector; Children; Rectal Ozone; CNS

Treatments: Other: Rectal ozone sessions; Other: Conventional rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT07153627

KFSIRB200-623

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Other: Rectal ozone sessions

Group 2

Active Comparator group

Description:

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

Treatment:

Other: Conventional rehabilitation program