Neonatal fungal infection Neonatal Diseases Neonatal fungal infection
Conditions
Interventions
The regimens in the two intervention groups was 6 and 3 mg/kg of fluconazole (DIFLUCAN®
Pfizer Italia S.p.A.
Latina/Roma
Italy) every third day for the first two weeks, then every other day.
Six weeks (in infants with birth weight less than 1000 g, i.e. Extremely Low Birth Weight [ELBW]) and four weeks (in the infants
Sponsors
Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All neonates with birth weight less than 1500 g (i.e. Very Low Birth Weight [VLBW]) born within the study period, whether at one of the eight Institutions or elsewhere, were eligible for the study.
Exclusion criteria
Exclusion criteria: 1. Parental refusal 2. Admission after 72 hours of life 3. Death prior to 72 hours of life 4. Liver failure (defined as three-fold elevation of Aspartate Aminotransferase [AST] and/or Alanine Aminotransferase [ALT] above the reference values)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study was to evaluate the effectiveness of 3 and 6 mg/kg fluconazole compared with placebo in the prevention of Candida colonisation and infection in the preterm very low birth weight neonates admitted to the participant NICUs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of the incidence of Gram-positive and Gram-negative sepsis 2. Mortality (overall and Candida-attributable) 3. Rate of progression from colonisation to infection 4. Necrotising enterocolitis 5. Ligation of patent ductus arteriosus 6. Threshold retinopathy of prematurity requiring surgery 7. Severe (grade 3-4) intraventricular haemorrhage 8. Bronchopulmonary dysplasia 9. Alteration of liver function as measured by serum AST, ALT, direct bilirubin and gamma-Glutamyl Transferase (gGT) values at baseline and at the end of all administrations | — |
Countries
Italy
Outcome results
None listed