Wesstrom 1979.
| Methods | Random assignment to one of 4 groups initially, high end hole, high side hole, low end hole or low side hole catheter. After the first 15 months the side hole groups were dropped and the final 4 months randomization was to high or low placement of end hole catheters only. | |
| Participants | 62 term and preterm infants, requiring umbilical arterial catheterisation for medical care. | |
| Interventions | 39 infants had end hole catheters, 23 had side hole catheters. | |
| Outcomes | Thrombosis on angiography performed at removal was the primary outcome variable. Necrotising enterocolitis not determined; clinical vascular compromise not stated. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Insufficient information presented to ascertain allocation masking. |
| Allocation concealment? | High risk | Masking does not appear to have been attempted. Random assignment to one of 4 groups initially, high end hole, high side hole, low end hole or low side hole catheter. After the first 15 months the side hole groups were dropped and the final 4 months randomization was to high or low placement of end hole catheters only. |
| Blinding? All outcomes | High risk | Masking of outcome assessment was not attempted. |
| Incomplete outcome data addressed? All outcomes | Unclear risk | All infants appear to have been accounted for; there were nine infants among the 71 subjects for whom autopsy or angiography were not available. |
| Free of selective reporting? | Low risk | |
| Free of other bias? | Unclear risk | Random assignment to one of 4 groups initially, high end hole, high side hole, low end hole or low side hole catheter. After the first 15 months the side hole groups were dropped and the final 4 months randomization was to high or low placement of end hole catheters only |