PMID- 19504425
OWN - NLM
STAT- MEDLINE
DCOM- 20100316
LR  - 20131121
IS  - 1098-8785 (Electronic)
IS  - 0735-1631 (Linking)
VI  - 27
IP  - 1
DP  - 2010 Jan
TI  - Comparison of fluconazole and nystatin oral suspensions for prophylaxis of 
      systemic fungal infection in very low birthweight infants.
PG  - 73-8
LID - 10.1055/s-0029-1224871 [doi]
AB  - We compared the efficacy and safety of fluconazole and nystatin oral suspensions 
      for the prevention of systemic fungal infection (SFI) in very low birthweight 
      infants. A prospective, randomized clinical trial was conducted over a 15-month 
      period, from May 1997 through September 1998, in 80 preterm infants with 
      birthweights <1500 g. The infants were randomly assigned to receive oral 
      fluconazole or nystatin, beginning within the first week of life. Prophylaxis was 
      continued until full oral feedings were attained. Blood and urine cultures were 
      obtained at enrollment and then weekly thereafter. Thirty-eight infants were 
      randomly assigned to receive oral fluconazole (group I), and 42 infants were 
      assigned to receive nystatin (group II). Birthweight, gestational age, and risk 
      factors for fungal colonization and SFI at the time of randomization and during 
      the hospital course were similar in both groups. SFI developed in two infants 
      (5.3%) in group I and six infants (14.3%) in group II. The difference between 
      these two rates was not statistically significant (relative risk, 0.37; 95% 
      confidence interval, 0.08 to 1.72). There were no deaths in group I and six 
      deaths in group II (P = 0.03). Two infants died of neonatal sepsis, and four 
      deaths were related to necrotizing enterocolitis and/or spontaneous intestinal 
      perforation. No deaths were due to SFI. Enrollment was halted before completion 
      and the study did not attain adequate power to detect a hypothesized drop in SFI 
      rate from 15 to 5%. Although the results cannot justify any conclusion about the 
      relative efficacy of fluconazole versus nystatin in prevention of SFI, the 
      significantly higher mortality rate in the nystatin group raises questions about 
      the relative safety of this medication.
CI  - Thieme Medical Publishers.
FAU - Violaris, Kimon
AU  - Violaris K
AD  - Division of Neonatology, Department of Pediatrics, Morgan Stanley Children's 
      Hospital of New York-Presbyterian, Columbia University, New York, New York 10032, 
      USA. kv2145@columbia.edu
FAU - Carbone, Tracy
AU  - Carbone T
FAU - Bateman, David
AU  - Bateman D
FAU - Olawepo, Olajide
AU  - Olawepo O
FAU - Doraiswamy, Brinda
AU  - Doraiswamy B
FAU - LaCorte, Meena
AU  - LaCorte M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20090605
PL  - United States
TA  - Am J Perinatol
JT  - American journal of perinatology
JID - 8405212
RN  - 0 (Antifungal Agents)
RN  - 1400-61-9 (Nystatin)
RN  - 8VZV102JFY (Fluconazole)
SB  - IM
MH  - Administration, Oral
MH  - Antifungal Agents/*administration & dosage
MH  - Fluconazole/*administration & dosage
MH  - Humans
MH  - Infant, Newborn
MH  - *Infant, Very Low Birth Weight
MH  - Mycoses/*drug therapy
MH  - Nystatin/*administration & dosage
MH  - Treatment Outcome
EDAT- 2009/06/09 09:00
MHDA- 2010/03/17 06:00
CRDT- 2009/06/09 09:00
PHST- 2009/06/09 09:00 [entrez]
PHST- 2009/06/09 09:00 [pubmed]
PHST- 2010/03/17 06:00 [medline]
AID - 10.1055/s-0029-1224871 [doi]
PST - ppublish
SO  - Am J Perinatol. 2010 Jan;27(1):73-8. doi: 10.1055/s-0029-1224871. Epub 2009 Jun 
      5.