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

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

Detailed Description
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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

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

Conditions
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Hemangioma

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisolone<br>Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks | Drug: Prednisolone<br>* 2mg/kg/day for 16weeks<br>* Other names: steroid;|
| Experimental: Propranolol<br>Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks | Drug: Propranolol<br>* 2mg/kg/day for 16weeks<br>* Other names: beta-blocker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO | The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction. | After 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Reduction in Hemangioma Volume From Baseline | Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks)) | After 16 weeks | 
| Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks | Number of Participants in which, the Heart rate fell to <70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to <70% of acceptable age related minimum post-dose with child awake | up to 16weeks | 
| Number of Participants With Change in Color as Compared to Baseline | Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color | After 16 weeks | 
| Number of Participants With Size Reduction of Ulceration | size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication) | After 16 weeks | 
| Number of Participants With Reepithelialzation in 16weeks | Number of participants with Reepithelialzation in 16weeks.. | After 16 weeks | 
| Number of Participants With Stop of Proliferation | Number of participants whose hemangioma stop proliferating in 16weeks | After 16 weeks | 
| Number of Participants With Regression | Number of participants whose hemangioma showed regression in 16 weeks. | Within 16 weeks | 
| Number of Participants With Drug Compliance Within 16 Weeks | We checked Number of participants with Drug compliance within 16 weeks | After 16 weeks | 
| Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks | Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks.. | up to 16weeks | 
| Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks | Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks.. | up to 16weeks | 
| Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks | Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks.. | up to 16weeks | 
| Number of Participants With Growth Retardation Within 16 Weeks | Number of Participants with Growth Retardation within 16 weeks.. | up to 16weeks | 
| Number of Participants With Gastroesophageal Reflux Within 16 Weeks | Number of Participants With Gastroesophageal reflux within 16 weeks.. | up to 16weeks | 
| Number of Participants With Adverse Drug Reaction | All symptoms associated adverse drug reaction will be checked | up to 16weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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steroid, Hemangioma, Propranolol, prednisolone