Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study|
- reduction in size of hemangioma [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
- Tolerability of medication [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: propranolol for treatment of hemangiomas
Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
propranolol 0.5 mg/kg p.o. QID x 4 - 6 months
Active Comparator: Prednisolone
Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
1.0 mg/kg p.o. BID x 4-6 months
Other Name: pediapred
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967226
|Contact: Jennifer Gode, RN||202 476 firstname.lastname@example.org|
|Contact: Nancy Bauman, MD||202 476 4270|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20111|
|Contact: Jennifer Gode, RN 202-476-4270 email@example.com|
|Contact: Nancy Bauman, MD 202 476 4270|
|Principal Investigator:||Nancy M Bauman, MD||Children's Research Institute, Children's National Medical Center|