Variable | Fluconazole (n=93) | Nystatin (n=94) | Control (n=91) | p Value† | RR (95% CI) |
---|---|---|---|---|---|
Mean time in NICU (day) | 46±24 | 45±20 | 47±25 | 0.87 | – |
Sepsis (%) | 48 | 40 | 49 | 0.40 | – |
Necrotising enterocolitis (stage 2 or 3) (%) | 8.6 | 9.6 | 9.9 | 0.95 | – |
Threshold retinopathy of prematurity (requiring surgery) (%) | 9.7 | 10.6 | 18.7 | 0.13 | – |
Severe (grade 3 or 4) intraventricular haemorrhage (%) | 14 | 11.7 | 14.3 | 0.85 | – |
Bronchopulmonary dysplasia (%) | 14 | 18.1 | 18.7 | 0.64 | – |
Death from any cause before hospital discharge (n (%)) | 8 (8.6) | 8 (8.5) | 11 (12.1) | 0.64 | – |
Invasive infection (n (%)) | 3 (3.2) | 4 (4.3) | 15 (16.5) | <0.001 | 3.253‡ (1.147 to 9.226) |
2.575§ (1.066 to 6.221) | |||||
Overall Colonisation (at least 1 site) (n (%)) | 10 (10.8) | 11 (11.7) | 39 (42.9) | <0.001 | 3.013‡ (1.706 to 5.321) |
2.795§ (1.631 to 4.789) | |||||
Two or more sites colonisation (n (%)) | 6 (6.5) | 5 (5.3) | 28 (30.8) | <0.001 | 3.484‡ (1.665 to 7.290) |
4.058§ (1.790 to 9.198) | |||||
Natively fluconazole-resistant candida species (n (%)) | 1 (1) | 0 | 2 (2.1) | – | – |
Progression from Colonisation to Invasive Infection (n (%)) | 3/10 (30) | 3/11 (36) | 15/39 (38) | 0.48 | – |
Death (n (%)) | |||||
From any cause before hospital discharge | 8 (8.6) | 8 (8.5) | 11 (12.1) | 0.64 | – |
Attributable to fungal infection | 1 (1.1) | 1 (1.1) | 3 (3.3) | 0.42 | – |
↵* Plus-minus values are means ±SD.
↵† p Values were calculated with the use of χ2 test for comparing proportions and Kruskal–Wallis test for comparing continuous variables.
↵‡ RRs are for the fluconazole group vs the control group.
↵§ RRs are for the nystatin group vs the control group.
NICU, neonatal intensive care unit.