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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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