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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group: | Experimental | 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 |
|
| Historical control group | No Intervention | Ten infants (1-12 months of age) treated with propranolol will be identified from a Dermatology Database. Patients will be considered as controls if they were treated with propranolol before 1 year of age and had digital photography documentation of their hemangioma. | |
| Angiogenesis marker control group | No Intervention | The angiogenesis marker control group will consist of 6 -10 patients seen in the Dermatology clinic for conditions other than IH and not receiving corticosteroids or beta blockers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadolol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with at least 75% improvement in the extent of the hemangioma | Baseline, 6months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with at least 50% improvement in the extent of the hemangiomas | The proportion of subjects with at least 50% improvement in the extent of the hemangiomas | Baseline and 6 months |
| The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol. |
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Inclusion Criteria:
Intervention Group
Historical Control Group
Angiogenesis Marker Control Group
Exclusion Criteria:
Intervention Group
Historical Control Group:
Angiogenesis Marker Control Group:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Pope, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009248 | Nadolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol. |
| 6 months |
| The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment. | The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment. | 6 months |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |