Matlow 1999.
| Methods | Randomized controlled trial | |
| Participants | 1189 neonates admitted to the NICU for whom IV lipid therapy was ordered. NICU of Paediatric Hospital, Canada | |
| Interventions | Administration set changes at 24 or 72 hours. Eight per cent of babies randomly assigned to study more than once | |
| Outcomes | Mortality | |
| Notes | Exclusions: patients receiving blood or blood products, disconnection of the set for longer than 4 hours or without sterile gauze coverage
Central catheters: mixed (proportion unknown)
PN: 100%
Loss to follow‐up: not clear, 45.9% of catheters were not sampled. Nil for mortality Data based on first randomization when babies were randomly assigned more than once to study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate method of random sequence generation Quote: "Infants requiring IV lipid treatment were randomly assigned to have IV sets changed on a 72 hour schedule, in a 3:1 ratio" (abstract) Quote: "Patients were randomized in pharmacy" (abstract) Quote: "Using a table of assignments by random number" (p. 488) Quote: "The ratio was altered to between 1:3 and 1:6 periodically when an imbalance in the numbers in the two treatment groups was observed" (p. 488) |
| Allocation concealment (selection bias) | Low risk | Randomly assigned in pharmacy, adequate concealment |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed, not feasible because of study design |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not discussed, not feasible because of study design |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome blinding possible but not discussed |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Inadequate attrition data provided n = 1278 randomly assigned (979 = 72 hours, 250 = 24 hours). Only 500 of those assigned to 72 hours and 191 of those assigned to 24 hours completed the study |
| Selective reporting (reporting bias) | Low risk | No pre‐protocol reported |
| Other bias | Unclear risk | Unequal group numbers |