Acquired Brain Injury, Cognitive Disability, Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric
Conditions
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.
Interventions
OTHERHyperbaric oxygen therapy
Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
OTHERConventional rehabilitation
Patients received conventional rehabilitation alone.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed