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

NCT06954376 | Completed

• 1 other identifier: KFSIRB200-137.
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nutritional intake functionality

  Eight months post-intervention

• Visual function assessment

  Eight months post-intervention

Study Arms (2)

Hyperbaric oxygen therapy group

EXPERIMENTAL

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

Other: Hyperbaric oxygen therapy

Control group

ACTIVE COMPARATOR

Patients received conventional rehabilitation alone.

Other: Conventional rehabilitation

Interventions

Hyperbaric oxygen therapy OTHER

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

Hyperbaric oxygen therapy group

Conventional rehabilitation OTHER

Patients received conventional rehabilitation alone.

Control group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatrics, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)