The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Hemangioma

Treatments: Drug: Prednisolone; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01908972

12172-MM-231

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

Full description

• Randomized (A group : propranolol, B group : prednisolone)
• A group : 3 days admission and medication for 16 weeks
• B group : medication for 16 weeks without admission
• Hemangioma volume comparison by using MRI
• other measurement and drug adverse reaction monitoring

Enrollment: 34 patients

Sex: All

Ages: Under 9 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Prednisolone

Active Comparator group

Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Treatment:

Drug: Prednisolone

Propranolol

Experimental group

Description:

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Treatment:

Drug: Propranolol