Prophylactic fluconazole is effective in preventing fungal colonisation and infection in preterm neonates: a multicentre, randomised trial in Italy

Completed

Conditions: eonatal fungal infection
Neonatal Diseases
Neonatal fungal infection

Registration Number: ISRCTN85753869

Lead Sponsor: Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 267

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Assessment of the incidence of Gram-positive and Gram-negative sepsis<br>2. Mortality (overall and Candida-attributable)<br>3. Rate of progression from colonisation to infection<br>4. Necrotising enterocolitis<br>5. Ligation of patent ductus arteriosus<br>6. Threshold retinopathy of prematurity requiring surgery<br>7. Severe (grade 3-4) intraventricular haemorrhage<br>8. Bronchopulmonary dysplasia<br>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