Status:
COMPLETED
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hemangioma
Eligibility:
All Genders
Up to 9 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
Detailed 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 comparis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01908972
Start Date
June 1 2013
End Date
May 1 2015
Last Update
December 19 2018
Active Locations (1)
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1
Seould National University Hospital
Seoul, South Korea, 110-744