Bauman 2014.

Methods	Design: parallel, 2 arms Country: USA Method of randomisation: pre‐generated encrypted schedule (Page 324) Blinding: single‐blind/investigator Location: Children's National Medical Center Length of follow‐up: until 4 months
Participants	Diagnosis: actively proliferating and symptomatic IH Sex: females: 14; males: 5 Age: 2 weeks to 6 months Inclusion criteria: infants with symptomatic haemangiomas Exclusion criteria: inadequate social support, non‐proliferating IH, other treatment for IH, liver disease, abnormal blood glucose level (BG), hypertension, hypotension, reactive airway disease, cardiac anomalies, and PHACE Number of randomised children: 19
Interventions	Intervention A (number of children: 11): propranolol 2.0 mg/kg/d orally 3 times daily Intervention B (number of children: 8): prednisolone 2.0 mg/kg/d orally twice daily
Outcomes	Primary outcome: reduction in size of haemangioma, measured by the proportional change in the total surface area based on the lesion's outer margin dimensions at 4 months Secondary outcome: adverse events, graded by severity (1 to 5)
Notes	Trial registration: NCT00967226 Funder: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Center for Research Resources of the National Institutes of Health (Page 330) Role of funder: only financial support A priori sample size estimation: yes (planned sample size: 55 children) Conducted: between 1 September 2010 and 1 August 2012 Declared conflicts of interest: yes (page 330)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: " ...were randomised ... using a CNMC institutional tamper‐proof, pregenerated encrypted schedule..." Page 324 Comment: Authors reported information about adequate random sequence generation.
Allocation concealment (selection bias)	Low risk	Quotes: " ...were randomised ... using a CNMC institutional tamper‐proof, pregenerated encrypted schedule..." Page 324. "The CNMC research pharmacy dispensed study drugs." Page 324 Comment: Authors reported information about adequate allocation concealment.
Blinding of participants (Performance bias)	Unclear risk	Quote: "Unblinded caretakers received counselling and written instructions to administer the medication 15 minutes before meals. (...) Caretakers were trained to recognize signs of hypoglycaemia, hypotension, and bradycardia that would warrant withholding of medication." Page 324 Comment: Unclear information was reported regarding the impact of lack of blinding for caretakers in the development of this trial.
Blinding of personnel (performance bias)	Low risk	Quote: "At enrolment, the blinded investigators assigned a number (...). The same blinded investigator repeated the measurements of size and skin involvement monthly." Page 324 Comment: Authors reported information about adequate blinding of personnel.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Unblinded caretakers received counselling and written instructions to administer the medication 15 minutes before meals. (...) Caretakers were trained to recognize signs of hypoglycaemia, hypotension, and bradycardia that would warrant withholding of medication." Page 324 Comment: Unclear information was reported regarding the impact of lack of blinding for caretakers in the development of this trial.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Authors performed intention‐to‐treat analysis; all children were analysed for the primary outcome.
Selective reporting (reporting bias)	Low risk	All outcomes mentioned in the methods were reported on in the results.
Other bias	Unclear risk	Quote: "The study was terminated prior to targeted enrolment at the DSMB's recommendation owing to severe AEs described herein that prompted early withdrawal of 6 of the 8 prednisolone participants." Page 325 Comment: Reason for termination of trial could be a potential source of bias.