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 |
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Outcomes | Fungal colonisation and invasive fungal infection Duration of mechanical ventilation and duration of intensive care admission |
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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 |
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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 |