CompletedPhase 2ACTRN12611000004965

Propranolol for infantile haemangiomas

A Pilot Randomized Double Blind Placebo Control Study to assess the efficacy and safety of Propranolol hydrochloride to treat Infantile Haemangiomas in children between the ages of 9 weeks to 5 years.


Sponsor

Sydney Children's Hospital

Enrollment

40 participants

Start Date

Jun 30, 2009

Study Type

Interventional

Conditions

Summary

Sydney Children's Hospital is doing a study to see whether haemangiomas of infancy (strawberry marks) which are no longer flat or which have continued to grow in spite of oral corticosteroids (cortisone), or present when the baby is too old for steroid treatment, will stop growing and /or shrink when treated with propranolol. A recent report of 11 cases suggests that propranolol may be helpful in shrinking haemangiomas of infancy.


Eligibility

Sex: Both males and femalesMin Age: 9 WeekssMax Age: 5 Yearss

Inclusion Criteria1

  • children between the ages of 9 weeks to 5 years with infantile hemangiomas that are deep, or in sites that could impair function or aesthetic disfigurement, or are too late for corticosteroid therapy or that failed to respond to corticosteroid therapy

Exclusion Criteria1

  • infantile hemangiomas requiring urgent treatment due to impingement on vital structures, contraindications to propranolol such as wheezing or PHACE syndrome (Posterior fossae of the brain, hemangiomas, arterial anomalies, cardiac anomalies and eye anomalies, due to the theoretical risk of cerebral ischemia) extracutaneous hemangiomas that can not be assessed by clinical photography and volume estimation, or inability to participate or follow study treatment and assessment plan.

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Interventions

Propranolol hydrochloride oral solution 2mg/kg/day divided three times daily for 24 weeks

Propranolol hydrochloride oral solution 2mg/kg/day divided three times daily for 24 weeks


Locations(1)

Australia

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ACTRN12611000004965


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