NCT00004436.

Methods	Parallel‐group, phase III, RCT
Participants	1 month to 8 months of age, male and female. Presence of haemangioma meeting at least 1 of the following criteria: vision threatening, severe anatomic distortion, or other complications Age: 1 to 8 months Sex: all Country: USA
Interventions	All children received oral prednisone daily for 3 weeks. Children were then randomised to receive either placebo or leuprolide intramuscularly every 3 weeks, whilst continuing oral prednisone. If the tumour did not respond, the leuprolide was administered every 2 weeks.
Outcomes	Safety and efficacy: tumours were assessed at 1, 3, 6 weeks and 3 and 6 months
Notes	The study was declared completed in 2005; however, we were unable to locate a report of the findings.