Nadolol Versus Propranolol in Children With Infantile Hemangiomas

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 1-6 months corrected age

• Written parental informed consent

• At least one of the following:

• Size: hemangioma >1.5 cm on the face or >3 cm on other body parts

• Causing or with potential for functional impairment (e.g. amblyogenic IH, ulcerated hemangioma)

• Causing or with potential for cosmetic disfigurement (e.g. nasal tip, glabella location)

Exclusion Criteria:

• Contraindications to beta-blockers

• Hypotension

• Bradycardia

• Hypoglycemia

• Cardiac disease associated with decreased ejection fraction and/or > second degree heart block

• Bronchospasm (including bronchial asthma)

• Allergic rhinitis

• Corrected gestational age less than 1 month at screening

• Patients with PHACES cerebral arteriopathy at risk of stroke

• Patients and/or breastfeeding mothers receiving treatment with anti-arrhythmic agents, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators, hypoglycemic agents, neuroleptics, antiacids, benzodiazepines, thyroxine, warfarin

• Patients treated with an oral beta-blocker or other agent (e.g. systemic steroids, vincristine) within 2 weeks from randomization

• Patients treated with topical timolol within 1 week from randomization

• Vascular tumors other than infantile hemangioma (e.g. pyogenic granuloma, hemangioendothelioma)