| Methods |
Single center randomized study. Masking of allocation; Yes. Masking of intervention; No. Completeness of follow up; Yes. Masking of outcome; No. |
| Participants |
50 term and preterm infants requiring umbilical arterial catheterisation for clinical care. |
| Interventions |
Heparin at 1 unit/mL in the infusate and the flush compared to no heparin in either the infusate or the flush. |
| Outcomes |
Clinical ischemic phenomena, hematuria, clotting studies, Aortic thrombi on aortograms performed after 24 to 72 hours or at autopsy. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Allocation clearly described: A pad containing randomly ordered group designations was used, the top page torn off for each patient, assignments not visible until torn off. |
| Allocation concealment? |
Low risk |
Masking of allocation: As noted above. A pad containing randomly ordered group designations was used, the top page torn off for each patient, assignments not visible until torn off. |
| Blinding?
All outcomes |
High risk |
Masking of intervention: Not attempted.
Masking of outcome: Not attempted for most outcomes, aortograms were read by a radiologist unaware of group assignment. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Completeness of follow‐up: Yes. |
