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NCT Number: NCT06954376

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

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.

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Key information

Conditions

Hyperbaric Oxygen Therapy Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Cognitive Disability Craniocerebral Trauma Nervous System Diseases Neuroprotective Pediatric Trauma, Nervous System Wounds and Injuries

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

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

conventional rehabilitation

Other

Patients received conventional rehabilitation alone.

Primary outcomes

  1. Communication Function Classification System

    Time frame: Eight months post-intervention

    The Communication Function Classification System (CFCS) was implemented to assess cognitive and speech capabilities across five levels of communicative competence.

    • Level I: Effective bidirectional communication (no need for external aids).
    • Level II: Consistent communication with familiar partners, occasional need for aids.
    • Level III: Communication requires significant effort and aids with familiar partners.
    • Level IV: Minimal communication, even with familiar partners.
    • Level V: No effective communication.

Secondary outcomes

  1. Nutritional intake functionality

    Time frame: Eight months post-intervention

    Nutritional intake functionality was evaluated utilizing the Functional Oral Intake Scale (FOIS). This seven-point scale was structured to differentiate between tube-dependent nutrition and total oral intake capabilities.

    • Level 1: Tube-dependent, no oral intake.
    • Level 2: Tube-dependent, minimal oral intake (e.g., ice chips).
    • Level 3: Tube-dependent, inconsistent oral intake of pureed foods.
    • Level 4: Oral intake of pureed foods only.
    • Level 5: Oral intake of soft foods.
    • Level 6: Oral intake of regular diet with modifications.
    • Level 7: Unrestricted oral intake (regular diet).

  2. Visual function assessment

    Time frame: Eight months post-intervention

    Visual function assessment was conducted through visual evoked potential testing, providing objective measurements of visual pathway integrity. Neurodevelopmental status was comprehensively evaluated using the Griffiths Mental Development Scales (GMDS). The GMDS yielded both subscale scores and an overall General Quotient (GQ).

    • ≥90: Normal development.
    • 80-89: Mild disability.
    • 70-79: Moderate disability.
    • <70: Severe disability.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2025
Registry last updated
May 1, 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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