Aydemir 2011a.
Methods | Randomised controlled trial | |
Participants | 185 VLBW infants | |
Interventions | Oral nystatin 100,000 U/ml 8 hourly (N = 94) versus normal saline placebo* (N = 91) every third day versus until the 30th day after birth (or 45th day in ELBW infants) | |
Outcomes | Fungal colonisation and invasive infection Death prior to hospital discharge Emergence of fungi with native azole resistance Adverse drug reactions |
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Notes | Setting: Zekai Tahir Burak Maternity Hospital, Ankara, Turkey; 2008 to 2009 *Report states placebo‐controlled but unclear how this was achieved The same infants form the oral nystatin group in both Aydemir 2011a and Aydemir 2011b |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Computer‐generated allocation |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Report states placebo‐controlled but unclear how this was achieved |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Report states placebo‐controlled but unclear how this was achieved |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Report states placebo‐controlled but unclear how this was achieved |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |