Nadolol for Proliferating Infantile Hemangiomas

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Nadolol

Criteria

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