Hyperbaric Oxygen TherapyNCT06954376
Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability
A study testing Hyperbaric oxygen therapy and Conventional rehabilitation in people with Hyperbaric Oxygen Therapy and Neuroprotective, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric
- What is being tested?
- Hyperbaric oxygen therapy and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Positive family history of degenerative brain insults.
- Behavioral problems.
- Hyperbaric oxygen therapy contraindications:
- Active epilepsy.
- Respiratory insufficiency.
- Uncontrolled heart failure.
Show all 9Show fewer
- Eustachian tube dysfunction.
- Tympanic membrane rupture.
- Mechanical ventilation dependency.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric, Acquired Brain Injury, Cognitive Disability
- Being tested
- Hyperbaric oxygen therapy, Conventional rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyOther
Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation.
Conventional rehabilitationOther
Patients received conventional rehabilitation alone.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy group | Experimental | Patients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation. Receives: Other: Hyperbaric oxygen therapy |
| Control group | Active comparator | Patients received conventional rehabilitation alone. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight months post-intervention
Secondary outcomes (2)
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).
Measured: 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.
Measured: Eight months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Abdel Hamid Gaml, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954376
- Sponsor's protocol ID
- KFSIRB200-137.
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability
- ClinicalTrials.gov ID
- NCT06954376
- Acronym / sponsor ID
- KFSIRB200-137.
- Conditions
- Hyperbaric Oxygen Therapy, Neuroprotective, Pediatric, Acquired Brain Injury, Cognitive Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy group | Experimental | Other: Hyperbaric oxygen therapyPatients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation. |
| Control group | Active comparator | Other: Conventional rehabilitationPatients received conventional rehabilitation alone. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Positive family history of degenerative brain insults.
- Behavioral problems.
- Hyperbaric oxygen therapy contraindications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyPatients received hyperbaric oxygen therapy (HBOT) using a monochamber hyperbaric chamber in addition to conventional rehabilitation. | Other | Hyperbaric oxygen therapy group |
| Conventional rehabilitationPatients received conventional rehabilitation alone. | Other | Control group |
Primary outcome
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.
2 secondary outcomes
Nutritional intake functionality
Time frame: Eight months post-intervention
Visual function assessment
Time frame: Eight months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy and Conventional rehabilitation in people with Hyperbaric Oxygen Therapy and Neuroprotective, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Function Classification System (time frame: Eight months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.