Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
| Status: | Terminated |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | December 2014 |
Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study
Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one
year of life and do not need treatment. Others require treatment because they cause
significant symptoms such as pain, or difficulty with breathing, eating or ambulating.
Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 -
2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have
sought other ways to treat them. Recently, the use of propranolol, a heart medication, was
serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side
effects than steroids but it is not yet known if it works as well as steroids. This study
seeks to compare the effect and the side effects of propranolol versus steroids for treating
hemangiomas that cause symptoms in infants.
year of life and do not need treatment. Others require treatment because they cause
significant symptoms such as pain, or difficulty with breathing, eating or ambulating.
Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 -
2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have
sought other ways to treat them. Recently, the use of propranolol, a heart medication, was
serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side
effects than steroids but it is not yet known if it works as well as steroids. This study
seeks to compare the effect and the side effects of propranolol versus steroids for treating
hemangiomas that cause symptoms in infants.
Infants with symptomatic hemangiomas will be enrolled. Magnetic resonance imaging will be
completed before starting medication if the extent of the hemangioma is not evident on
clinical examination alone. Infants will be randomized to receive either propranolol or
steroids for 4-6 months. Hemangioma response will be measured and compared monthly as will
tolerability of the medications. Additionally, urine specimens will be collected at each
visit to determine if markers are present that can predict response to therapy.
Additionally, any hemangiomas that are excised will be examined for genetic markers to aid
in predicting response to therapy.
completed before starting medication if the extent of the hemangioma is not evident on
clinical examination alone. Infants will be randomized to receive either propranolol or
steroids for 4-6 months. Hemangioma response will be measured and compared monthly as will
tolerability of the medications. Additionally, urine specimens will be collected at each
visit to determine if markers are present that can predict response to therapy.
Additionally, any hemangiomas that are excised will be examined for genetic markers to aid
in predicting response to therapy.
Inclusion Criteria:
- infants with symptomatic hemangiomas
Exclusion Criteria:
- asthma
- diabetes
- hypertension
- hypotension
- hypoglycemia
- liver failure
- previous treatment for hemangiomas
We found this trial at
1
site
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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