Parikh 2007.
Methods | Randomised controlled trial | |
Participants | 121 VLBW infants < 3 days old (one infant was withdrawn on day of randomisation and not included in any analyses) "Critically ill" infants and infants with biochemical evidence of hepatic insufficiency were not eligible for inclusion |
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Interventions | Fluconazole (N = 60) 6 mg/kg every third day for the first week after birth, then every day until four weeks versus "sugar solution" placebo (N = 60). Administered intravenously and then enterally 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 | Most invasive fungal infection was due to non‐albicans Candida species (mainly C. glabrata) which were relatively less susceptible to fluconazole. Setting: KEM Hospital and Seth GS Medical College, Mumbai; 2003 to 2004 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
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 | Near‐complete follow‐up |