This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Why is your child being asked to take part in this study? Your child is being invited to take part in this research study because he/she is being treated with an important medicine called fluconazole. This medicine treats or tries to prevent infection with fungus or yeast. While we have used this medicine for many years, we are still not certain of the best way (How much? How often?) to give it to infants. What is the purpose of this research study? Fluconazole is a medicine that is often used in adults and children for the treatment or prevention of fungus or yeast infection. The medicine is also used in infants who do not usually have serious side effects from it. We want to learn more about this medicine to better understand what happens to this medicine in the body and how long it stays in the bloodstream. Prematurity, age, weight, kidney function, and illness affect how the body can handle a medicine. Small amounts of blood can be tested in the laboratory to measure what is happening to drugs in the body. This type of study is called a pharmacokinetic study. Pharmacokinetic studies of fluconazole have been performed in adults and children, but very limited information is available for infants. Technology is now available that allows us to measure fluconazole in very small blood samples, to more completely study this medicine in small babies. This information may allow us to improve how we dose fluconazole to future babies. This study is being conducted at 10 hospitals in the United States. About 50 babies will take part in this study at all sites. About 10 infants will be studied at CNMC.
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