Rectal Ozone as Neuroprotector Post CNS Insult in Children

Al-Azhar University120 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Rectal Ozone Neuroprotector CNS Insult Children

Interventions

Rectal ozone sessionsOTHER

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

Conventional rehabilitation programOTHER

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Al-Azhar University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.