Violaris 2010.
Methods | Randomised controlled trial | |
Participants | 80 VLBW infants Haemodynamically unstable infants and infants with severe congenital anomalies or abnormal liver function tests were not eligible to participate |
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Interventions | Nystatin (100,000 units/kg/day) in each side of the mouth (N = 42) versus fluconazole (4 mg/kg) orally (N = 38) beginning on day five after birth Medications were continued until full oral feedings were attained or systemic fungal infection was diagnosed |
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Outcomes | Invasive fungal infection, invasive bacterial infection, biochemical indices related to liver function, mortality | |
Notes | Setting: Brooklyn Hospital Center, New York; 1997 to 1998 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Computerised randomisation and allocation |
Blinding (performance bias and detection bias) All outcomes | High risk | Unable to blind interventions |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind interventions |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unable to blind interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow up |