Effectiveness and Safety of Low and High Initial Doses of Oral Propranolol for Treating Ulcerated Infantile Hemangioma in Young Children

What this Trial Is About

Infantile hemangioma IH is a common benign tumor in infants, affecting about 4%-5% of this population. Some IH cases develop serious complications like ulceration. This research evaluates the effectiveness and safety of starting treatment with different doses of oral propranolol for ulcerated IH in young children, aiming to provide clearer prospective data on dosing strategies. Participants receive propranolol at either a low dose of 1 mgkgday or a high dose of 2 mgkgday. The study is randomized and compares these two dosing regimens over time to assess how they influence healing of the ulcerated hemangiomas. This trial is conducted in Chinese children aged from around 1 month to 4 years. During the study, researchers monitor the time it takes for the ulcer to heal, the resolution of the hemangioma six months after starting treatment, and any adverse events that occur. The treatment and observation period lasts up to 1.5 years, with ongoing follow-up to evaluate safety and effectiveness. Participants are regularly assessed throughout this period to track outcomes and any side effects.

Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma