Status:
TERMINATED
An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy
Lead Sponsor:
Dayton Children's Hospital
Collaborating Sponsors:
United States Department of Defense
Kettering Health Network
Conditions:
Cerebral Palsy
Cerebral Palsy, Spastic
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
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...
Detailed Description
The study proposed herein is a randomized, double blind study to evaluate the therapeutic effectiveness of HBO in children (ages 3-8 years) with a diagnosis of spastic CP. Ninety-four children will be...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00290186
Start Date
August 1 2005
End Date
November 1 2012
Last Update
August 28 2014
Active Locations (2)
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1
Dayton Children's Hospital
Dayton, Ohio, United States, 45404-1815
2
Wound Healing and Hyperbaric Medicine Center
Wpafb, Ohio, United States, 45433-5546