Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability
- Conditions
- Hyperbaric Oxygen TherapyNeuroprotectivePediatricAcquired Brain InjuryCognitive Disability
- Registration Number
- NCT06954376
- Lead Sponsor
- Kafrelsheikh University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
-
Positive family history of degenerative brain insults.
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Behavioral problems.
-
Hyperbaric oxygen therapy contraindications:
- Active epilepsy.
- Respiratory insufficiency.
- Uncontrolled heart failure.
- Eustachian tube dysfunction.
- Tympanic membrane rupture.
- Mechanical ventilation dependency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Communication Function Classification System 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 Outcome Measures
Name Time Method Nutritional intake functionality 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).Visual function assessment 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.
Trial Locations
- Locations (1)
Kafrelsheikh University
🇪🇬Kafr Ash Shaykh, Kafrelsheikh, Egypt