Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability

Kafrelsheikh University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06954389

KFSIRB200-137

Details and patient eligibility

About

This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.

Full description

Pediatric acquired brain injury (ABI) represents a significant challenge in modern medicine, necessitating innovative therapeutic approaches to enhance recovery and minimize long-term neurological deficits.

Hyperbaric oxygen therapy (HBOT), which delivers oxygen at pressures exceeding atmospheric levels, has emerged as a promising neuroprotective intervention for various forms of pediatric brain injury, including traumatic brain injury (TBI), anoxic-ischaemic encephalopathy (AIE), and stroke.

Enrollment: 120 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 4-12 years.
• Diagnosed with pediatric acquired brain injury confirmed by neurological examination and magnetic resonance imaging.
• Presence of neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infection, stroke, tumor, hypoxia).

Exclusion criteria

• Positive family history of degenerative brain insults.

• Behavioral problems.

• Contraindications to hyperbaric oxygen therapy :

  • 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 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