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Duration and intensity of fluconazole for prophylaxis in preterm neonates: a meta-analysis of randomized controlled
Datian Che1, Hua Zhou2, Te Li3
1Department of Respiratory Medicine, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.
Background:
The currently available evidence shows fluconazole is an effective prophylaxis treatment against invasive fungal infections in preterm neonates in neonatal intensive care units (NICUs). However, the duration and dosing of this prophylaxis treatment remain controversial. Thus, a meta-analysis and systematic review are necessary.
Methods:
PubMed and EMBASE were systematically searched with no restrictions. All relevant citations that compared prophylactic fluconazole and no prophylaxis were considered for inclusion. Pooled effect estimates were obtained through fixed- and random-effects meta-analyses, and a meta-regression was used to explore the sources of heterogeneity in the data.
Results:
Five independent randomized controlled clinical trials (RCTs) involving 1006 preterm neonates were identified. Compared with no prophylaxis, the overall combined relative risks (RRs) of invasive fungal infection with the 28- and 42-day durations of prophylactic fluconazole were 0.80 (95 % CI 0.48-1.35, p = 0.4048) and 0.30 (95 % CI 0.15-0.58, p = 0.0004), respectively. The fluconazole dose had no significant impact on the RR of invasive fungal infections. The RR of mortality presented no significant differences between prophylactic fluconazole and no prophylaxis (RR 0.82, 95 % CI 0.60 to 1.12, p = 0.2093).
Conclusions:
Prophylaxis with fluconazole for 42 days was found to be superior to no prophylaxis as a strategy for preventing invasive fungal infection in preterm infants in NICUs except in terms of mortality. The dosing regimen of prophylactic fluconazole may have no impact on the outcome; however, due to the limitations of the available data, further research is needed.
Insights
Fluconazole prophylaxis effectively prevents invasive fungal infections in preterm infants in neonatal intensive care units (NICUs). A 42-day treatment duration is superior to shorter courses or no prophylaxis, though mortality rates remain unaffected.
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Pharmacology
Background:
- Invasive fungal infections (IFIs) pose a significant risk to preterm neonates in NICUs.
- Fluconazole is recognized as an effective prophylactic agent against IFIs in this vulnerable population.
- Optimal duration and dosing strategies for fluconazole prophylaxis remain debated, necessitating further investigation.
Purpose of the Study:
- To systematically review and meta-analyze the efficacy of fluconazole prophylaxis in preventing IFIs in preterm neonates.
- To compare different durations of fluconazole prophylaxis.
- To assess the impact of fluconazole prophylaxis on mortality in preterm neonates.
Main Methods:
- A comprehensive search of PubMed and EMBASE was conducted without restrictions.
- Five randomized controlled trials (RCTs) involving 1006 preterm neonates were included in the meta-analysis.
- Fixed- and random-effects models were used to calculate pooled relative risks (RRs), with meta-regression exploring heterogeneity.
Main Results:
- A 42-day duration of prophylactic fluconazole significantly reduced the risk of IFIs (RR 0.30, p=0.0004) compared to no prophylaxis.
- A 28-day duration showed no significant difference in IFI risk (RR 0.80, p=0.4048).
- Fluconazole dosage did not significantly impact IFI risk, and no significant difference in mortality was observed between groups (RR 0.82, p=0.2093).
Conclusions:
- Prophylactic fluconazole for 42 days is a superior strategy for preventing IFIs in preterm infants in NICUs, excluding mortality benefits.
- The dosing regimen may not influence outcomes, but further research is recommended due to data limitations.
