Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study
N/A
5 Months
Both
Hemangioma of Infancy
Trial Information
Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study
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.
Inclusion Criteria:
- infants with symptomatic hemangiomas
Exclusion Criteria:
- asthma
- diabetes
- hypertension
- hypotension
- hypoglycemia
- liver failure
- previous treatment for hemangiomas
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
reduction in size of hemangioma
Outcome Time Frame:
4-6 months
Safety Issue:
No
Principal Investigator
Nancy M Bauman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Research Institute, Children's National Medical Center
Authority:
United States: Institutional Review Board
Study ID:
IRB 4502
NCT ID:
NCT00967226
Start Date:
July 2009
Completion Date:
December 2014
Related Keywords:
- Hemangioma of Infancy
- hemangioma
- Hemangioma
Name | Location |
|---|---|
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
