Fox 1999.
Methods | Randomized controlled trial | |
Participants | 166 neonates receiving TPN. NICU, Canada | |
Interventions | Administration set changes at 24 or 48 hours | |
Outcomes |
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Notes | Exclusions: not stated Central catheters: > 30% PN: 100% Loss to follow‐up: 10.8%, nil for mortality | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate random sequence generation Quote: "A random number table was used to allocate infants in a one to two ratio" (p. 150) |
Allocation concealment (selection bias) | Unclear risk | Not discussed |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed, not feasible because of research design |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not discussed, not feasible because of research design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome blinding not discussed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Adequately reported: n = 166 randomly assigned, 149 cultured infusate (therefore 14 not sent as PN ceased, 3 deceased, 1 crossed over) Roughly equates to equal attrition between groups |
Selective reporting (reporting bias) | Low risk | No pre‐protocol |
Other bias | High risk | Did not monitor set interruptions Two types of administration sets in use. Quote: "determined by the type of IV pump in use" (p. 151) but not reported by group Quote: "Unit of measurement was infusate sample not patient" (p. 151), but study was randomized per participant |