Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

• Decrease in Size of Hemangioma (Length x Width) in Square mm [ Time Frame: 4-5 months after initiating therapy ] [ Designated as safety issue: No ]
  A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.
  
  

• Tolerability of Medication [ Time Frame: enrollment until study close out or withdrawal up to 9 months ] [ Designated as safety issue: Yes ]
  All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.
  
  
• Number of Serious Adverse Events (SAEs) [ Time Frame: enrollment until study close out or withdrawal up to 9 months ] [ Designated as safety issue: Yes ]
  Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
  
  
• Growth and Development Adverse Events [ Time Frame: enrollment to study withdrawal or close out up to 9 months ] [ Designated as safety issue: No ]
  Number of Growth and Development AEs in each study arm
  
  
• Pulmonary/Respiratory Adverse Events [ Time Frame: enrollment through study close out or withdrawal, up to 9 months ] [ Designated as safety issue: Yes ]
  Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm
  
  
• Allergy/Immunology Adverse Events [ Time Frame: enrollment through study closeout or study withdrawal up to 9 months ] [ Designated as safety issue: No ]
  Number of allergy/immunology AE per study arm
  
  
• Dermatologic Adverse Events [ Time Frame: enrollment to study close out or withdrawal up to 9 months ] [ Designated as safety issue: No ]
  Number of Dermatologic Adverse Events in each study arm.
  
  
• Endocrinologic Adverse Events [ Time Frame: enrollment to close out or study withdrawal up to 9 months ] [ Designated as safety issue: No ]
  Number of Endocrinologic AEs (of which adrenal crisis does not overlap).
  
  
• Gastrointestinal Adverse Events [ Time Frame: enrollment to study withdrawal or study close out up to 9 months ] [ Designated as safety issue: No ]
  Number of Gastrointestinal AEs in each arm
  
  
• Infectious Adverse Events [ Time Frame: enrollment to study withdrawal or close out up to 9 months ] [ Designated as safety issue: No ]
  Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)
  
  
• Metabolic or Laboratory AEs [ Time Frame: enrollment to study withdrawal or close out up to 9 months ] [ Designated as safety issue: No ]
  Number of Metabolic or Laboratory AEs in each study arm.
  
  
• Vascular Adverse Events [ Time Frame: enrollment to study withdrawal or close out up to 9 months ] [ Designated as safety issue: No ]
  Number of Vascular AEs in each study arm.
  
  
• Constitutional Adverse Events [ Time Frame: enrollment to study close out or withdrawal up to 9 months ] [ Designated as safety issue: No ]
  Number of constitutional AEs in each study arm.
  
  

Infants with symptomatic hemangiomas will be enrolled. Magnetic resonance imaging will be completed before starting medication if the extent of the hemangioma is not evident on clinical examination alone. Infants will be randomized to receive either propranolol or steroids for 4-6 months. Hemangioma response will be measured and compared monthly as will tolerability of the medications. Additionally, urine specimens will be collected at each visit to determine if markers are present that can predict response to therapy.

Additionally, any hemangiomas that are excised will be examined for genetic markers to aid in predicting response to therapy.