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. 2015 Oct 24;2015(10):CD003478. doi: 10.1002/14651858.CD003478.pub5

Sims 1988.

Methods Quasi‐randomised controlled trial; odd or even hospital number allocation
Participants 67 infants of birth weight < 1250 grams
Interventions Nystatin 1 ml orally, 8 hourly (N = 33) versus no drug (N = 34)
Treatment from inclusion until one week after endotracheal extubation
Outcomes Fungal colonisation and invasive fungal infection
Duration of mechanical ventilation and duration of intensive care admission
Notes Setting: Los Angeles County+University of Southern California Medical Centre, 1985 to 1986
The study took place during a period of overcrowding in the intensive care unit; 222 infants with a birthweight < 1250 grams were born during a 12‐month period; 55 died within 48 hours, 88 relatively healthy infants were transferred elsewhere and 67 of the remaining 88 infants were recruited to the study.
One infant in the control group had Candida albicans pneumonia supported by postmortem evidence. All the other affected infants had positive urine and blood cultures
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) High risk Quasi‐randomised
Blinding (performance bias and detection bias) 
 All outcomes High risk Unblinded
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unblinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Unblinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Complete follow‐up