Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability

Kafrelsheikh University

Status: Completed

Conditions: Hyperbaric Oxygen Therapy; Neuroprotective; Acquired Brain Injury; Pediatric; Cognitive Disability

Treatments: Other: Conventional rehabilitation; Other: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06954376

KFSIRB200-137.

Details and patient eligibility

About

This research aimed to investigate the effectiveness of hyperbaric oxygen therapy as a neuroprotective strategy for improving neurological outcomes in pediatric patients who have sustained acquired brain injury.

Full description

Hyperbaric oxygen therapy (HBOT) is a medical treatment that delivers high-concentration oxygen in a pressurized chamber. It was developed initially from diving physiology research and popularized by Dutch surgeon Boerema for its life-sustaining plasma oxygen diffusion under hyperbaric conditions.

The fundamental mechanism of HBOT operates through Henry's Law, enabling unprecedented increases in tissue oxygen partial pressures that surpass levels achievable in normal atmospheric conditions.

Enrollment: 120 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients aged 4-12 years with acquired brain injury.
• Confirmed neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, hypoxia) via MRI/neurological exam.

Exclusion criteria

• Positive family history of degenerative brain insults.

• Behavioral problems.

• Hyperbaric oxygen therapy contraindications:

  • Active epilepsy.
  • Respiratory insufficiency.
  • Uncontrolled heart failure.
  • Eustachian tube dysfunction.
  • Tympanic membrane rupture.
  • Mechanical ventilation dependency.

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

Hyperbaric oxygen therapy group

Experimental group

Description:

Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation.

Treatment:

Other: Hyperbaric oxygen therapy

Control group

Active Comparator group

Description:

Patients received conventional rehabilitation alone.

Treatment:

Other: Conventional rehabilitation