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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?

Hemangioma

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: June 2013

Completed Date: May 2015

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01908972