Hemangioma of Infancy | Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
Hemangioma of Infancy research study
What is the primary objective of this 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.
Who is eligible to participate?
Inclusion Criteria: - infants with symptomatic hemangiomas Exclusion Criteria: - asthma - diabetes - hypertension - hypotension - hypoglycemia - liver failure - previous treatment for hemangiomas
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Hemangioma of Infancy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:propranololpropranolol 0.5 mg/kg orally, 4 per day - 4-6 months
Drug:Prednisolone1.0 mg/kg orally, 2 per day 4-6 months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
propranolol for treatment of hemangiomasAssessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
PrednisoloneAssessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
Start Date: July 2009
Completed Date: December 2014
Phase: Phase 2
Primary Outcome: Decrease in Size of Hemangioma (Length x Width) in Square mm
Secondary Outcome: Tolerability of Medication
Study sponsors, principal investigator, and references
Principal Investigator: Nancy M Bauman, MD
Lead Sponsor: Nancy Bauman
Pérez RS, Mora PC, Rodríguez JD, Sánchez FR, de Torres Jde L. [Treatment of infantile hemangioma with propranolol]. An Pediatr (Barc). 2010 Feb;72(2):152-4. doi: 10.1016/j.anpedi.2009.05.019. Epub 2009 Jul 23. Spanish.