Kicklighter 2001.
Methods | Randomised placebo‐controlled trial | |
Participants | 103 VLBW infants < 3 days old Infants with evidence of liver failure, congenital heart disease, or congenital defects needing surgery were not eligible for inclusion |
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Interventions | Fluconazole 6 mg/kg (N = 53) or placebo (N = 50) every third day for one week than daily for three more weeks. Administered intravenously and then oro‐gastrically when tolerated | |
Outcomes | Fungal colonisation and invasive infection Emergence of fluconazole resistance Adverse drug reactions Death prior to hospital discharge |
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Notes | Setting: Medical University of South Carolina; 1998 to 1999 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Random assignment by separate trials centre |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo‐controlled |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |