| Methods |
Single center randomised study.
Masking of allocation: Yes
Masking of intervention: No
Completeness of follow up: Yes
Masking of outcomes: No |
| Participants |
144 term and preterm infants. |
| Interventions |
Heparin bonded polyurethane catheter compared with standard PVC catheter. |
| Outcomes |
Aortic thrombosis, blanching of feet or legs, persistent hypertension. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
Masking of allocation:Yes, Opaque sequentially numbered envelopes opened after enrollment. |
| Blinding?
All outcomes |
High risk |
Masking of intervention: No, catheters have a different appearance.
Masking of outcomes: Most of the outcomes were not masked. Abdominal sonograms were read by radiologists masked as to group assignment. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Completeness of follow‐up: Yes. |
| Free of selective reporting? |
Low risk |
|
| Free of other bias? |
Unclear risk |
Clear description of determination of required sample size; this was actually achieved. Hypothesized a reduction in incidence of "aortic clots or associated complications" from 45% to 20% |
