The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
研究概览
简要总结
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
详细描述
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Hormone deficiency patient
- •Pulmonary disease (asthma)
- •diabetic ketoacidosis
- •laser treatment history
研究组 & 干预措施
Prednisolone
Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks
干预措施: Prednisolone (Drug)
Propranolol
Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks
干预措施: Propranolol (Drug)
结局指标
主要结局
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
时间窗: After 16weeks
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.
次要结局
- 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 With Stop of Proliferation(After 16 weeks)
- Number of Participants With Regression(Within 16 weeks)
- Number of Participants With Drug Compliance Within 16 Weeks(After 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(up to 16weeks)
- Number of Participants With Growth Retardation Within 16 Weeks(up to 16weeks)
- Percent Reduction in Hemangioma Volume From Baseline(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(up to 16weeks)
- Number of Participants With Change in Color as Compared to Baseline(After 16 weeks)
- Number of Participants With Size Reduction of Ulceration(After 16 weeks)
- Number of Participants With Reepithelialzation in 16weeks(After 16 weeks)
- Number of Participants With Gastroesophageal Reflux Within 16 Weeks(up to 16weeks)
- Number of Participants With Adverse Drug Reaction(up to 16weeks)