Nadolol for Proliferating Infantile Hemangiomas

The Hospital for Sick Children20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infantile Hemangioma

Interventions

NadololDRUG

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Proportion of subjects with at least 75% improvement in the extent of the hemangioma

Time frame: Baseline, 6months

Secondary Outcomes

The proportion of subjects with at least 50% improvement in the extent of the hemangiomas

Time frame: Baseline and 6 months

The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.

The percentage of patients with \>75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.

Time frame: 6 months

The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.

Time frame: 6 months

Data from ClinicalTrials.gov

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