NCT01072045.

Methods	Parallel‐group, phase II, RCT
Participants	Up to 2 years of age, male and female, absence of cardiopathy, clinically diagnosed haemangioma in proliferative or involutive phase with relative indication for clinical treatment, itemised as follows: lesion causing alteration of regional anatomy with no systemic or functional damage and with a diameter greater than 1 cm; lesion causing aesthetic deformity; lesion causing local repetitive complications such as ulceration, bleeding, or local irritation; lesion causing partial damage of orifices; lesion causing psychological compromise. Age: up to 2 years Sex: all Country: Brazil
Interventions	Propranolol (2 mg/kg/day) given orally, divided into 2 doses for initial 60 days, versus prednisone (2 mg/kg/day) given orally, divided into 2 doses for initial 60 days
Outcomes	Primary outcome: Reduction in tumour volume based on direct measurement and photographic analysis (weekly in first 2 months and twice a week in following months) Secondary outcome: Evidence of collateral effects (weekly in first 2 weeks and twice a week in the following months)
Notes	This study has been completed. Study completion date: December 2014