An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy
Stopped early · Not applicable
Conditions studied: Cerebral Palsy, Cerebral Palsy, Spastic
In brief
The study is to evaluate the effectiveness of hyperbaric treatments and the potential longer-term effects in children between the ages of 3 and 8 years with spastic cerebral palsy (CP). One group will receive 100% oxygen and the other group will receive the equivalent of 21% oxygen (room air). The children will receive pre-treatment testing (baseline). After 40 experimental treatments are completed, the children will be retested at 0, 3, and 6 months to evaluate any changes.
Key facts
- Study ID
- NCT00290186
- Run by
- Dayton Children's Hospital
- People needed
- 49
- Starts
- 2005-08-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2014-08-28
Who can join
Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female children, ages 3 to 8 years with a diagnosis of spastic cerebral palsy.
- No documented evidence of hypoxic-ischemic encephalopathy (HIE). Hypoxic-ischemic encephalopathy (HIE) is not one of the major causes of CP.
- Medically cleared to participate. Your child's primary care physician will be asked to medically clear your child before entering the study.
- Able to pass pretest screening exercise. Each child will undergo the following screening exercise to determine the likelihood of being able to participate in the study: In order to assess ability to tolerate the placement of the oxygen hood in the hyperbaric setting, a hyperbaric oxygen hood will be placed upon the shoulders, or body of your child (depending upon size of your child) and with encouragement and comforting by you and study nurse, the child will be asked to maintain the placement of the hood for 15 minutes. Each child will be asked to blow through a straw, blow the nose, drink through a straw, or to swallow on command.
You may not qualify if…
- Any previous HBO treatments.
- Thoracic surgery within 6 months of beginning the study.
- Unstable epilepsy as determined by a history of having had more than one major motor (generalized or partial tonic/clonic) seizure within the past six months. Having multiple motor seizures, requiring more than three anticonvulsant drugs for seizure control; or requiring changes in seizure medications more than once per month.
- Significant pulmonary dysfunction as determined by a history of chronic pulmonary disease, cystic fibrosis, interstitial lung disease, or chronic shortness of breath or cough. Uncontrolled asthma/reactive airway disease.
- Significant behavioral problems requiring medication.
- Any major congenital deformities of the brain or spinal cord.
- Active pneumothorax (collapsed lung).
- Recent cancer treatment with cisplatinum, bleomycin, or doxorubicin.
- Certain heart problems that cause the heart to pump poorly as determined by a history of congenital heart disease, cardiomyopathy, or symptoms of chest pain, dizziness, and shortness of breath.
- Optic neuritis.
- Diabetics requiring insulin therapy.
- Spherocytosis.
- Major GI reflux with frequent emesis.
- Botulinum toxin A (Botox) treatments within 6 months of entering study.
- Before entering the study, we will require that chronic medications be unchanged for the prior three months except for minor dosage adjustments.
Where it is running
- Dayton Children's Hospital — Dayton, Ohio, United States
- Wound Healing and Hyperbaric Medicine Center — Wpafb, Ohio, United States
Full record on ClinicalTrials.gov
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