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. 2013 Sep 15;2013(9):CD003588. doi: 10.1002/14651858.CD003588.pub3

Fox 1999.

Methods Randomized controlled trial
Participants 166 neonates receiving TPN. NICU, Canada
Interventions Administration set changes at 24 or 48 hours
Outcomes
  • IR‐BSI

  • All‐cause BSI

  • Mortality

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