Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

Condition(s) targeted: Hemangioma of Infancy

Intervention: propranolol (Drug); Prednisolone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Children's Research Institute

Official(s) and/or principal investigator(s):
Nancy M Bauman, MD, Principal Investigator, Affiliation: Children's Research Institute, Children's National Medical Center

Overall contact:
linda haga, RN, Phone: 202 476 5221

Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating.

Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 -

2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: reduction in size of hemangioma

Secondary outcome: Tolerability of medication

Detailed description: 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.

Minimum age: N/A. Maximum age: 5 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- infants with symptomatic hemangiomas

Exclusion Criteria:

- asthma

- diabetes

- hypertension

- hypotension

- hypoglycemia

- liver failure

- previous treatment for hemangiomas

linda haga, RN, Phone: 202 476 5221

Children's National Medical Center, Washington, District of Columbia 20111, United States; Recruiting
Linda Haga, RN, Phone: 202-476-5221
Nancy Bauman, MD, Phone: 202 476 4270

Related publications:

Sánchez Pérez R, Cortes Mora P, González Rodríguez JD, Rodríguez Sánchez F, De la Peña de Torres J. [Treatment of infantile hemangioma with propranolol.] An Pediatr (Barc). 2009 Jul 22; [Epub ahead of print] Spanish. No abstract available.

Denoyelle F, Leboulanger N, Enjolras O, Harris R, Roger G, Garabedian EN. Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. Int J Pediatr Otorhinolaryngol. 2009 Aug;73(8):1168-72. Epub 2009 May 29.

Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. No abstract available.

Starting date: July 2009
Ending date: December 2012
Last updated: August 26, 2009