Hemangioma of Infancy Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment