Hogeling 2011.

Methods	Design: parallel, 2 arms Country: Australia Method of randomisation: minimisation method Blinding: participants, caregivers, physicians, statistician Location: Sydney Children's Hospital Length of follow‐up: 6 months
Participants	Diagnosis: IHs that had a deep component or were located in sites that could impair function or result in aesthetic disfigurement Sex: female: 27; male: 12 Age: between 9 weeks and 5 years Inclusion criteria: children between the ages of 9 weeks and 5 years with IHs that had a deep component or were located in sites that could impair function or result in aesthetic disfigurement, were too late for corticosteroid therapy, or that had failed to respond to corticosteroid therapy Exclusion criteria: any children with IHs requiring urgent treatment due to impingement on vital structures, children with contraindications to propranolol, such as wheezing or PHACE syndrome, and those children with extracutaneous haemangiomas that could not be assessed by clinical photography and volume estimation Number of randomised children: 40
Interventions	Intervention A (number of children: 20): propranolol hydrochloride oral solution 2 mg/kg per day. Administration was initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24. After 6 months of treatment, the trial medication was tapered by decreasing to one‐half dose for 1 week followed by one‐quarter dose for 1 week, and then discontinuing. Intervention B (number of children: 20): placebo oral solution. The placebo oral solution had a similar taste and smell and an identical dispensing bottle.
Outcomes	Outcomes were not classified as primary or secondary: Response to therapy: volume estimation at weeks 0, 4, 8, 12, 16, 20, and 24 by using serial hemispheric measurements of tumour volume. IH colour (redness or blueness) and elevation Adverse events
Notes	Trial registration: ACTRN12611000004965 Funder: Sydney Children's Hospital Foundation Role of funder: not reported A priori sample size estimation: yes Conducted: from June 2009 to December 2010 Declared conflicts of interest: yes (page e259)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Patients were enrolled in the trial by study physicians and randomised into 4 groups using minimization by the clinical trials pharmacist. The study physician telephoned the clinical trials pharmacist who then assigned sequence of randomisation.” Page 260 Comment: Authors reported information about adequate random sequence generation.
Allocation concealment (selection bias)	Low risk	Quote: “Patients were enrolled in the trial by study physicians and randomised into 4 groups using minimization by the clinical trials pharmacist. The study physician telephoned the clinical trials pharmacist who then assigned sequence of randomisation.” Page 260 Comment: Authors reported information about adequate allocation concealment.
Blinding of participants (Performance bias)	Low risk	Quotes: “Participants, caregivers, and physicians were blinded to group status.” Page 260 “The placebo oral solution had a similar taste and smell and an identical dispensing bottle.” Page 260 Comment: Authors reported information about adequate blinding of participants.
Blinding of personnel (performance bias)	Low risk	Quotes: “Participants, caregivers, and physicians were blinded to group status.” Page 260 "The placebo oral solution had a similar taste and smell and an identical dispensing bottle." Page 260 Comment: Authors reported information about adequate blinding of personnel.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: “The IH colour (redness or blueness) and elevation were assessed by the blinded investigator and were given scores by the investigators.” Page 261 Comment: Authors reported information about adequate blinding of outcome assessment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	5% of children were lost at follow‐up. Page 261
Selective reporting (reporting bias)	High risk	All outcomes were predefined and reported. However, information about variance of information (standard deviations) associated to mean estimation were ommited.
Other bias	Low risk	No other biases were identified.