Hemangioma | The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Hemangioma research study
What is the primary objective of this study?
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
Who is eligible to participate?
Inclusion Criteria: - Hemangioma patient ( 0 ~ 9 months old) - No treatment before - 10 ~ 20 % volume increase in 2 ~ 4 weeks - Hemangioma that caused organ function - Hemangioma that will cause aesthetic problem Exclusion Criteria: - Cardiovascular disease (impossible to use propranolol) - Drug adverse reaction or allergy history (propranolol, steroid) - Bradycardia, Atrioventricular block, atrial block - Cardiogenic Shock - Right heart failure (pulmonary hypertension) - Congestive heart failure - Hypotension - Peripheral nerve disease (moderate) - Angina - Hormone deficiency patient - Pulmonary disease (asthma) - diabetic ketoacidosis - laser treatment history
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
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:Prednisolone2mg/kg/day for 16weeks
Drug:Propranolol2mg/kg/day for 16weeks
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.
PrednisolonePatients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks
PropranololPatients who will receive propranolol medication 2 mg/kg/day for 16 weeks
Start Date: June 2013
Completed Date: May 2015
Phase: Phase 4
Primary Outcome: Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
Secondary Outcome: Percent Reduction in Hemangioma Volume From Baseline
Study sponsors, principal investigator, and references
Principal Investigator: Kyung-Duk Park, MD, Ph D
Lead Sponsor: Seoul National University Hospital