Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

NCT ID: NCT00967226

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-12-31

Brief 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.

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.

Conditions

Hemangioma of Infancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

propranolol for treatment of hemangiomas

Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas

Group Type: EXPERIMENTAL

propranolol

Intervention Type: DRUG

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

Prednisolone

Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

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

Interventions

propranolol

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

Intervention Type: DRUG

Prednisolone

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

Intervention Type: DRUG

Other Intervention Names

pediapred

Eligibility Criteria

Inclusion Criteria

• infants with symptomatic hemangiomas

Exclusion Criteria

• asthma
• diabetes
• hypertension
• hypotension
• hypoglycemia
• liver failure
• previous treatment for hemangiomas

• Minimum Eligible Age: 2 Weeks
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nancy Bauman

OTHER

Sponsor Role: lead

Responsible Party

Nancy Bauman

Professor, George Washington University, Attending Children;s National

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nancy M Bauman, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Research Institute, Children's National Medical Center

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

Perez RS, Mora PC, Rodriguez JD, Sanchez 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. No abstract available. Spanish.

Reference Type: BACKGROUND

PMID: 19631595 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19481268 (View on PubMed)

Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.

Reference Type: BACKGROUND

PMID: 18550886 (View on PubMed)

Bauman NM, McCarter RJ, Guzzetta PC, Shin JJ, Oh AK, Preciado DA, He J, Greene EA, Puttgen KB. Propranolol vs prednisolone for symptomatic proliferating infantile hemangiomas: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 Apr;140(4):323-30. doi: 10.1001/jamaoto.2013.6723.

Reference Type: DERIVED

PMID: 24526257 (View on PubMed)

Patel NJ, Bauman NM. How should propranolol be initiated for infantile hemangiomas: inpatient versus outpatient? Laryngoscope. 2014 Jun;124(6):1279-81. doi: 10.1002/lary.24363. Epub 2013 Dec 17. No abstract available.

Reference Type: DERIVED

PMID: 24347141 (View on PubMed)

Other Identifiers

NIH grant number 10179326

Identifier Type: -

Identifier Source: secondary_id

IRB 4502

Identifier Type: -

Identifier Source: org_study_id