COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Fluconazole prophylaxis in extremely low birth weight infants and neurodevelopmental outcomes and quality of life at 8 to 10 years of age

David A Kaufman, Amy L Cuff, Julia B Wamstad, Robert Boyle, Matthew J Gurka, Leigh B Grossman, Peter Patrick
Journal of Pediatrics 2011, 158 (5): 759-765.e1
21168853

OBJECTIVE: To examine the long-term effects of fluconazole prophylaxis in extremely low birth weight infants.

STUDY DESIGN: Neurodevelopmental status and quality of life of survivors from a randomized, placebo-controlled trial of fluconazole prophylaxis were evaluated at 8 to 10 years of life using the Vineland Adaptive Behavior Scales-II (VABS-II) and the Child Health Questionnaire Parent-Completed Form 28 (CHQ-PF28), respectively.

RESULTS: VABS-II Domain Scores for the fluconazole-treated (n = 21; 9.1 ± 0.7 years) compared with the placebo group (n = 17; 9.3 ± 0.8 years) were similar for communication [94.6 (±14.8) versus 92.6 (±12.6), P = .65], daily living skills [87.9 (±10.6) versus 87.4 (±9.3), P = .89], socialization [97.2 (±9.2) versus 94.4 (±7.9), P = .31], and motor skills [92.1 (±17.8) versus 95.1 (±14.6), P = .57]. Internalizing and externalizing behaviors and maladaptive behavior index were also similar. The CHQ-PF28 revealed no differences between the two groups regarding quality of life. Survivors were also happy or satisfied with school (90% versus 100%, P = .49), friendships (90% versus 88%, P = 1.00), and life (95% versus 100%, P = 1.00). Self esteem scores were 87.3 ± 15.7 versus 89.7 ± 10.4 (P = .59). There were also no differences between groups regarding emotional difficulties or behavior problems.

CONCLUSIONS: Fluconazole prophylaxis for the prevention of invasive Candida infections is safe in extremely low birth weight infants and does not appear to be associated with any long-term adverse effects on neurodevelopment and quality of life at 8 to 10 years of life.

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