Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-10-01

Brief Summary

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This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.

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Detailed Description

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Pediatric acquired brain injury (ABI) represents a significant challenge in modern medicine, necessitating innovative therapeutic approaches to enhance recovery and minimize long-term neurological deficits.

Hyperbaric oxygen therapy (HBOT), which delivers oxygen at pressures exceeding atmospheric levels, has emerged as a promising neuroprotective intervention for various forms of pediatric brain injury, including traumatic brain injury (TBI), anoxic-ischaemic encephalopathy (AIE), and stroke.

Conditions

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Hyperbaric Oxygen Therapy Neuroprotective Pediatric Acquired Brain Injury Motor Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen therapy group

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

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type OTHER

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

Control group

Patients received conventional rehabilitation alone.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Patients received conventional rehabilitation alone.

Interventions

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Hyperbaric oxygen therapy

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

Intervention Type OTHER

Conventional rehabilitation

Patients received conventional rehabilitation alone.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 4-12 years.
* Diagnosed with pediatric acquired brain injury confirmed by neurological examination and magnetic resonance imaging.
* Presence of neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infection, stroke, tumor, hypoxia).

Exclusion Criteria

* Positive family history of degenerative brain insults.
* Behavioral problems.
* Contraindications to hyperbaric oxygen therapy :

* Active epilepsy.
* Respiratory insufficiency.
* Uncontrolled heart failure.
* Eustachian tube dysfunction.
* Tympanic membrane rupture.
* Mechanical ventilation dependency.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No