Benjamin 2014.
Methods | Randomised controlled trial | |
Participants | 361 infants with BW < 750 grams and less than 120 hours old. Siblings were assigned to the same treatment group. Infants were excluded if they were receiving systemic antifungal therapy, were diagnosed with congenital or invasive candidiasis, or had liver or renal impairment. |
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Interventions | Fluconazole 6 mg/kg twice weekly (N = 188) versus normal saline placebo (N = 173) administered intravenously in infants with intravenous access, and enterally by orogastric tube to infants without intravenous access, for first six weeks of life. | |
Outcomes | Death Definite or probable invasive candidiasis Neurodevelopmental impairment at 18 to 22 months corrected age Length of stay Chronic lung disease Retinopathy of prematurity Necrotising enterocolitis |
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Notes | Setting: 32 NICUs in United States. November 2008 to January 2011. Trial registration: http://clinicaltrials.gov/show/NCT00734539) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Computer‐generated. Interactive voice recognition system randomisation (Almac). |
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. Blinding for the duration of the study, including at neurodevelopmental assessment at 19 to 22 months corrected age |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |