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Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study


Phase 2
N/A
5 Months
Open (Enrolling)
Both
Hemangioma of Infancy

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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 CenterWashington, District of Columbia  20010-2970