Clinical trial · Interventional
Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Serious adverse events with prednisolone, primarily temporary growth retardation, \<5th percentile.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemangioma of Infancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prednisolone | Drug | Prednisolone | ALIAS |
| propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- propranolol for treatment of hemangiomas
- description
- Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas
- interventionNames
- Drug: propranolol
- type
- ACTIVE_COMPARATOR
- label
- Prednisolone
- description
- Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
- interventionNames
- Drug: Prednisolone
Primary outcomes (1)
- measure
- Decrease in Size of Hemangioma (Length x Width) in Square mm
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Weeks
- Maximum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * infants with symptomatic hemangiomas Exclusion Criteria: * asthma * diabetes * hypertension * hypotension * hypoglycemia * liver failure * previous treatment for hemangiomas
References
Publications (5)
- BACKGROUNDPerez 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. PMID 19631595
- BACKGROUNDDenoyelle 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. PMID 19481268
- BACKGROUNDLeaute-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. PMID 18550886
- DERIVEDBauman 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. PMID 24526257
- DERIVEDPatel 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. PMID 24347141