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NCT Number: NCT07153627

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.

Recruiting

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University

Cairo, 11651, Egypt

Location status: Recruiting

Location contact

Abeer M Salamah, MD

SUB_INVESTIGATOR

Ahmed M Asfour, Master

CONTACT

[email protected]

00201017440223

Mohamed I Hussein, MD

SUB_INVESTIGATOR

Osama A Elagami, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rectal ozone sessions

Other

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

conventional rehabilitation program

Other

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

Primary outcomes

  1. Assessment of muscle Tone

    Time frame: 6 months post-sessions

    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.

Secondary outcomes

  1. Incidence of reduction in neuroinflammation

    Time frame: 6 months post-sessions

    Incidence of reduction in neuroinflammation will be recorded.

  2. Assessment of quality of life

    Time frame: 6 months post-sessions

    Assessment of quality of life including emotional well-being or social interaction will be recorded.

  3. Incidence of adverse effects

    Time frame: 6 months post-sessions

    Incidence of adverse effects will be recorded.

  4. Measurement of age-related response variability

    Time frame: 6 months post-sessions

    Age-related response variability by evaluating how different age groups respond to treatment will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Asfour, Master

CONTACT

[email protected]

00201017440223

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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