| Methods |
Design: parallel, 3 arms Country: Egypt Method of randomisation: unclear Blinding: not stated Location: Cairo University Hospital and Abo El‐Reesh Pediatric Hospital Length of follow‐up: 6 months |
| Participants |
Diagnosis: problematic infantile haemangiomas Sex: male: 6; female: 39 Age: 1 to 18 months Inclusion criteria: children with problematic IHs Exclusion criteria: any child with a known contraindication for propranolol or with ultrasound‐confirmed deeper components Number of randomised children: 45 |
| Interventions |
Intervention A (number of children: 15): oral propranolol was administered at dose of 2 mg/kg/day, divided into 2 daily doses. Intervention B (number of children: 15): topical propranolol was administered at dose of 1% ointment in a hydrophilic base, applied twice daily. Intervention C (number of children: 15): intralesional propranolol 1 mg in 1 mL of injection, administered on a weekly basis |
| Outcomes |
Outcome A: final response = excellent, good, fair, or poor Outcome B: side effects, including cardiovascular follow‐up Outcome C: rebound growth |
| Notes |
Trial registration: not stated Funder: no funder Role of funder: no role A priori sample size estimation: not stated Conducted: not stated Declared conflicts of interest: yes (page 651) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "(...) and those fit for inclusion were subsequently randomly divided into three groups as follows (...)." Page 647
Comment: There was insufficient information to assess this item as low or high. |
| Allocation concealment (selection bias) |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Blinding of participants (Performance bias) |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Blinding of personnel (performance bias) |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
There was insufficient information to assess this item as low or high. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No children were lost at follow‐up. |
| Selective reporting (reporting bias) |
Low risk |
Selective reporting bias was not detected. |
| Other bias |
Low risk |
No other biases were detected. |
