Document Detail

Prophylactic oral antifungal agents to prevent systemic candida infection in preterm infants.
MedLine Citation:
PMID:  14974017     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Systemic fungal infection has increased in prevalence in neonatal intensive care units (NICU) caring for very low birth weight infants. It is associated with a prolonged stay and an increase in morbidity and mortality. An assessment of the use of oral prophylactic antifungals to prevent systemic infection is needed.
OBJECTIVES: To assess whether the prophylactic administration of oral antifungal agents to very preterm infants reduces the occurrence of systemic fungal infection.
SEARCH STRATEGY: The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Searches were carried out up to July 2003 on the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 2, 2003), MEDLINE from 1966, EMBASE from 1980, CINAHL from 1992. Abstracts from SPR (1993 - 2003) and ESPR (1995 to 2002) were hand searched.
SELECTION CRITERIA: Randomized and quasi randomized controlled trials in very low birth weight or very preterm infants in which an oral antifungal agent was compared with placebo or no treatment or another oral antifungal agent
DATA COLLECTION AND ANALYSIS: Data were extracted using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of the trial quality and data extraction undertaken by each author. Results were reported using relative risk (RR) and risk difference (RD) and weighted mean difference (WMD). 95% confidence intervals were reported.
MAIN RESULTS: We identified three eligible trials, one comparing nystatin with no treatment (67 infants), one comparing miconazole with placebo (600 infants), and one comparing nystatin with fluconazole (21 infants). As the two trials comparing nystatin or miconazole with placebo or no treatment were clinically quite different, meta-analysis was not performed. In the trial of nystatin versus no treatment, systemic fungal infection was significantly reduced [RR 0.19 (0.04,0.78)] in the group treated with nystatin. In the study comparing miconazole with placebo there was no significant effect on systemic fungal infection [RR 1.32 (0.46,3.75)]. Neither study found a significant effect on mortality, and there was no significant difference in the mean number of days infants received ventilation or stayed in the neonatal intensive care unit. In the small trial comparing oral fluconazole with nystatin, no significant difference in systemic fungal infection [RR 0.17 (0.01, 2.84)] or mortality [RR 0.17 (0.01, 2.84)] was reported. Adverse drug reactions were not reported in any study.
REVIEWER'S CONCLUSIONS: There is insufficient evidence to support the use of prophylactic oral antifungal agents in very low birth weight infants in the neonatal intensive care unit. Randomised controlled trials in current neonatal practice settings are needed, comparing oral antifungal agents with placebo and with each other and including an assessment of side effects, in order to determine whether oral antifungal agents have a role in preventing systemic fungal infections in preterm infants.
N C Austin; B Darlow
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  The Cochrane database of systematic reviews     Volume:  -     ISSN:  1469-493X     ISO Abbreviation:  Cochrane Database Syst Rev     Publication Date:  2004  
Date Detail:
Created Date:  2004-02-19     Completed Date:  2004-06-29     Revised Date:  2013-06-28    
Medline Journal Info:
Nlm Unique ID:  100909747     Medline TA:  Cochrane Database Syst Rev     Country:  England    
Other Details:
Languages:  eng     Pagination:  CD003478     Citation Subset:  IM    
Neonatal Intensive Care Unit, Christchurch Women's Hospital, Christchurch, New Zealand, Private Bag 4711, Christchurch, New Zealand.
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MeSH Terms
Administration, Oral
Antifungal Agents / therapeutic use*
Candidiasis / prevention & control*
Candidiasis, Chronic Mucocutaneous / prevention & control
Fluconazole / therapeutic use
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / prevention & control*
Infant, Very Low Birth Weight
Miconazole / therapeutic use
Nystatin / therapeutic use
Randomized Controlled Trials as Topic
Reg. No./Substance:
0/Antifungal Agents; 1400-61-9/Nystatin; 22916-47-8/Miconazole; 86386-73-4/Fluconazole
Update In:
Cochrane Database Syst Rev. 2009;(4):CD003478   [PMID:  19821309 ]

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