Document Detail

Prophylactic oral/topical non-absorbed antifungal agents to prevent invasive fungal infection in very low birth weight infants.
MedLine Citation:
PMID:  19821309     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Invasive fungal infection is an important cause of mortality and morbidity in very preterm (< 32 weeks gestation) or very low birth weight (VLBW) infants. Clinical uncertainly exists about the effect of prophylactic oral/topical non-absorbed antifungals to reduce mucocutaneous colonisation and so limit the risk of invasive fungal infection in this population.
OBJECTIVES: To assess the effect of prophylactic oral/topical non-absorbed antifungal therapy on the incidence of invasive fungal infection, mortality and morbidity in VLBW infants.
SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 2, 2009), MEDLINE (1966 - May 2009), EMBASE (1980 - May 2009), conference proceedings, and previous reviews.
SELECTION CRITERIA: Randomised controlled trials that compared the effect of prophylactic oral/topical non-absorbed antifungal therapy versus placebo or no drug or another antifungal agent or dose regimen in very preterm or VLBW infants.
DATA COLLECTION AND ANALYSIS: Data were extracted using the standard methods of the Cochrane Neonatal Review Group with separate evaluation of trial quality and data extraction by each review author and synthesis of data using relative risk (RR) and risk difference (RD) and weighted mean difference (WMD).
MAIN RESULTS: Three trials, in which a total of 1625 infants participated, have compared oral/topical non-absorbed antifungal prophylaxis (nystatin or miconazole) with placebo or no drug. These trials had various methodological weaknesses including quasi-randomisation, lack of allocation concealment, and lack of blinding of intervention and outcomes assessment. The incidence of invasive fungal infection was very high in the control groups of two of the included trials. Meta-analysis found a statistically significant reduction in the incidence of invasive fungal infection [typical RR 0.19 (95% confidence interval (CI) 0.14, 0.27); typical RD -0.19 (95% CI -0.22,-0.16)] but substantial statistical heterogeneity was detected. A statistically significant effect on mortality was not found [typical RR 0.88 (95% CI 0.72, 1.06); typical RD -0.02 (95% CI -0.06, 0.01)]. Long-term outcomes were not assessed by any of the trials.One small trial (N = 21) that assessed the effect of oral/topical non-absorbed antifungal prophylaxis (nystatin) compared with systemic antifungal (fluconazole) prophylaxis was underpowered to exclude important clinical effects.
AUTHORS' CONCLUSIONS: The finding of a reduction in risk of invasive fungal infection in infants treated with oral/topical non-absorbed antifungal prophylaxis should be interpreted cautiously because of methodological weaknesses in the included trials. Further large randomised controlled trials in current neonatal practice settings are needed to resolve this uncertainty. These trials might compare oral/topical non-absorbed antifungal agents with placebo, with each other, or with systemic antifungal agents and should include an assessment of effect on long-term neurodevelopmental outcomes.
Nicola Austin; Brian A Darlow; William McGuire
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Review     Date:  2009-10-07
Journal Detail:
Title:  The Cochrane database of systematic reviews     Volume:  -     ISSN:  1469-493X     ISO Abbreviation:  Cochrane Database Syst Rev     Publication Date:  2009  
Date Detail:
Created Date:  2009-10-12     Completed Date:  2010-01-27     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    
NICU, Christchurch Womens Hospital, 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. 2013;3:CD003478   [PMID:  23543519 ]
Update Of:
Cochrane Database Syst Rev. 2004;(1):CD003478   [PMID:  14974017 ]

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