Clinical Trial: The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Brief Summary: The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
Detailed Summary:
- 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
Sponsor: Seoul National University Hospital
Current Primary Outcome: Hemangioma volume measured by MRI or SONO [ Time Frame: After 16weeks ]
Original Primary Outcome: Hemangioma volume measured by MRI [ Time Frame: After 16weeks ]
Current Secondary Outcome:
- Size changes from baseline [ Time Frame: After 16 weeks ]Measure the horizontal and vertical size (2-dimension)
- Heart rate change from Baseline at 16 weeks [ Time Frame: up to 16weeks ]Heart rate fall to <70% of acceptable age related minimum post-dose with child awake
- Change from Baseline in color [ Time Frame: After 16 weeks ]Red/Purple/Blue/Gray/Apricot
- Changes in Size of Ulceration [ Time Frame: After 16 weeks ]Measure the horizontal and vertical size (2-dimension)
- Whether or not Re-epithelized in 16weeks [ Time Frame: After 16 weeks ]Yes/No
- Stop time of proliferation [ Time Frame: After 16 weeks ]The time when hemangioma stop growing within 16 weeks
- Time of regression [ Time Frame: Within 16 weeks ]The time when hemangioma decreased to 75% of baseline size
- Drug compliance within 16 weeks [ Time Frame: After 16 weeks ]Check the number of having drugs and skip time.
- Change from Baseline in systolic blood pressure at 16 weeks [ Time Frame: up to 16weeks ]Systolic blood pressure fall of >25% of baseline postdose with child awake
- Changes from baseline in Glucose level at 16 weeks [ Time Frame: up to 16weeks ]Check the Glucose level whether to fall (to <50mg/dl)
- Whether the facial edema occurs within 16 weeks [ Time Frame: up to 16weeks ]Yes/No
- Whether growth retardation occurs within 16 weeks [ Time Frame: up to 16weeks ]When the subject do not grow in 16 weeks at all.
- Whether the Gastroesophageal reflux occurs within 16 weeks [ Time Frame: up to 16weeks ]Yes/No
- Number of Participants with Adverse drug reaction [ Time Frame: up to 16weeks ]All symptoms associated adverse drug reaction will be checked
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: July 9, 2013
Date Started: June 2013
Date Completion:
Last Updated: February 15, 2016
Last Verified: February 2016