Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
Information source: Children's Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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: Jennifer Gode, RN, Phone: 202 476 4270, Email: jgode@cnmc.org
Summary
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.
Clinical Details
Official title: Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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.
Eligibility
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
Locations and Contacts
Jennifer Gode, RN, Phone: 202 476 4270, Email: jgode@cnmc.org
Children's National Medical Center, Washington, District of Columbia 20111, United States; Recruiting Jennifer Gode, RN, Phone: 202-476-4270, Email: jgode@cnmc.org Nancy Bauman, MD, Phone: 202 476 4270
Additional Information
Related publications: Pérez RS, Mora PC, Rodríguez JD, Sánchez FR, de Torres Jde L. [Treatment of infantile hemangioma with propranolol]. An Pediatr (Barc). 2010 Feb;72(2):152-4. doi: 10.1016/j.anpedi.2009.05.019. Epub 2009 Jul 23. Spanish. 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. doi: 10.1016/j.ijporl.2009.04.025. 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. doi: 10.1056/NEJMc0708819.
Starting date: July 2009
Last updated: May 25, 2012
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