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 ]

We compared hemangioma volume measured by MRI or SONO, before and 16 weeks after medications.


Original Primary Outcome: Hemangioma volume measured by MRI [ Time Frame: After 16weeks ]

We compared hemangioma volume measured by MRI, before and 16 weeks after medications.


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