RecruitingNot ApplicableNCT07153627

Rectal Ozone as Neuroprotector Post CNS Insult in Children


Sponsor

Al-Azhar University

Enrollment

120 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

OTHERRectal ozone sessions

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

OTHERConventional rehabilitation program

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


Locations(1)

Al-Azhar University

Cairo, Egypt

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NCT07153627


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