NCT01010308

Nadolol for Proliferating Infantile Hemangiomas

Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Month – 1 Year
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy. The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.

Detailed description

Systemic corticosteroids are currently the most frequent used medication for treatment of problematic infantile hemangiomas (IH's). Since June 2008, systemic propranolol has been an important addition to the therapeutic options for problematic IH, allowing decreased dependence on the systemic corticosteroids. So far, we have found excellent response with propranolol with minimal short-term side effects. Studies, which compared nadolol and propranolol in children with other conditions, suggest that nadolol is safer and more efficacious than propranolol. In addition, it has better dosing schedules and less central nervous system (CNS) penetration, making it suitable even for patients with suspected or proven PHACES syndrome.

Conditions

• Infantile Hemangioma

Interventions

Type	Name	Description
DRUG	Nadolol	Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-05-01
• Completion: 2012-02-01
• First posted: 2009-11-10
• Last updated: 2021-08-19

Locations

1 site across 1 country: Canada