Manzoni 2007b.
Methods | Randomised controlled trial | |
Participants | 216 VLBW infants | |
Interventions | Fluconazole 3 mg/kg (N = 104) versus 6 mg/kg (N = 112) given every second day from birth for 30 days (or 45 days for ELBW infants (N = 216)) | |
Outcomes | Fungal colonisation and invasive infection Death prior to hospital discharge Emergence of fluconazole resistance |
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Notes | Setting: Eight level III neonatal units in Turin, Rome, Milan, or Pavia, Italy (2004 to 2006) Manzoni 2007b is the internal dose comparison of Manzoni 2007a intervention group |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Computer‐generated and allocated |
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 |