Pharmacokinetic Study of Fluconazole in Premature Infants

Seoul National University Hospital80 enrolled

Overview

The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Very Low Birth Weight Infant

Interventions

FluconazoleDRUG

Prophylactic fluconazole administration in VLBW infants

Eligibility

Sex: ALLMax age: 4 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * very low birth weight infant (birth weight \< 1,500 g) who were admitted to the NICU before day 3 of life * Informed consent from the parents Exclusion Criteria: * Major congenital anomaly * Expired within 72 hours of life * Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher) * Proven congenital or intrauterine fungal infection

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

drug level of fluconazole

four times drug level after 3th dose

Time frame: 30min later, 10-12hr later, at routine lab with interval of 1week

Data from ClinicalTrials.gov

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