Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2012 by Children's Research Institute.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Children's Research Institute

ClinicalTrials.gov Identifier:

NCT00967226

First received: August 26, 2009

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hemangioma of Infancy	Drug: propranolol Drug: Prednisolone	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Propranolol hydrochloride Propranolol Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Further study details as provided by Children's Research Institute:

Primary Outcome Measures:

reduction in size of hemangioma [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability of medication [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	70
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: propranolol for treatment of hemangiomas Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas	Drug: propranolol propranolol 0.5 mg/kg p.o. QID x 4 - 6 months
Active Comparator: Prednisolone Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.	Drug: Prednisolone 1.0 mg/kg p.o. BID x 4-6 months Other Name: pediapred

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


Ages Eligible for Study:	up to 5 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

infants with symptomatic hemangiomas

Exclusion Criteria:

asthma
diabetes
hypertension
hypotension
hypoglycemia
liver failure
previous treatment for hemangiomas

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967226

Contacts


Contact: Jennifer Gode, RN	202 476 4270	jgode@cnmc.org
Contact: Nancy Bauman, MD	202 476 4270

Locations


United States, District of Columbia
Children's National Medical Center	Recruiting
Washington, District of Columbia, United States, 20111
Contact: Jennifer Gode, RN 202-476-4270 jgode@cnmc.org
Contact: Nancy Bauman, MD 202 476 4270

Sponsors and Collaborators

Children's Research Institute

Investigators


Principal Investigator:	Nancy M Bauman, MD	Children's Research Institute, Children's National Medical Center

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Review.


Responsible Party:	Children's Research Institute
ClinicalTrials.gov Identifier:	NCT00967226 History of Changes
Other Study ID Numbers:	IRB 4502, NIH grant number 10179326
Study First Received:	August 26, 2009
Last Updated:	May 25, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Research Institute:


hemangioma

Additional relevant MeSH terms:


Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Methylprednisolone Methylprednisolone Hemisuccinate Methylprednisolone acetate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Propranolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-Antagonists	Anti-Arrhythmia Agents Anti-Inflammatory Agents Antiemetics Antihypertensive Agents Antineoplastic Agents Antineoplastic Agents, Hormonal Autonomic Agents Cardiovascular Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Neuroprotective Agents

ClinicalTrials.gov processed this record on March 02, 2015

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