Nadolol for Proliferating Infantile Hemangiomas
- Registration Number
- NCT01010308
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Intervention Group
- Infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement.
Historical Control Group
- Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years
Angiogenesis Marker Control Group
- Infants aged 1 month to 1 year attending dermatology clinic
Intervention Group
- Patients with PHACES syndrome (proven) or suspected PHACES (plaque like hemangioma awaiting imaging).
- Children with history of hypersensitivity to beta blockers
- Children with personal history or family history of a first degree relative with asthma
- Children with known renal impairment
- Children with known cardiac conditions which may predispose to heart blocks
- Personal history of hypoglycemia
- Children on medications that may interact with beta blockers
Historical Control Group:
- No digital photography available documenting IHs progression
Angiogenesis Marker Control Group:
- Children with IH
- Children on beta blocker or systemic corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group: Nadolol The patients in this study are infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years as a control group
- Primary Outcome Measures
Name Time Method Proportion of subjects with at least 75% improvement in the extent of the hemangioma Baseline, 6months
- Secondary Outcome Measures
Name Time Method The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment. 6 months The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.
The proportion of subjects with at least 50% improvement in the extent of the hemangiomas Baseline and 6 months The proportion of subjects with at least 50% improvement in the extent of the hemangiomas
The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol. 6 months The percentage of patients with \>75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada