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Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

NCT00967226 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-02-24

Study results available
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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.

Conditions

  • Hemangioma of Infancy

Interventions

DRUG

propranolol

propranolol 0.5 mg/kg orally, 4 per day - 4-6 months

DRUG

Prednisolone

1.0 mg/kg orally, 2 per day 4-6 months

Sponsors & Collaborators

  • Nancy Bauman

    lead OTHER

Principal Investigators

  • Nancy M Bauman, MD · Children's Research Institute, Children's National Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-01-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967226 on ClinicalTrials.gov