Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Hemangioma
About this trial
This is an interventional treatment trial for Hemangioma
Eligibility Criteria
Inclusion Criteria:
- Age 0 to < 9months
- Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment
- IH patients whose parents desire medical treatment for the IH
- Stable cardiac function
Exclusion Criteria:
- IH patients over 9 months of age.
- Hypersensitivity to propranolol
- Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient.
- Atrioventricular (AV) block
- Resting heart < 2 SD of normal*(below)
- Resting blood pressure < 2 SD of normal**(below)
- Wolff-Parkinson-White syndrome (WPW)
- History of unexplained syncope
- Bronchial asthma
- History of impaired renal or liver function
- Diabetes mellitus
Sites / Locations
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm 2
Other
Other
Group A: Corticosteroid with Placebo
Group B: Corticosteroid with Propranolol
Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.