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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury; Pediatric; Hyperbaric Oxygen Therapy; Cognitive Disability; Neuroprotective
• Intervention / Treatment: Other: Conventional rehabilitation; Other: Hyperbaric oxygen therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients received conventional rehabilitation alone.	Other: Conventional rehabilitation; Patients received conventional rehabilitation alone.
Experimental: Hyperbaric oxygen therapy group; Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation.	Other: Hyperbaric oxygen therapy; Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication Function Classification System	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.	Eight months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional intake functionality	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).	Eight months post-intervention
Visual function assessment	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.	Eight months post-intervention

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: KFSIRB200-137.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No