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Treatment prevents infections in preemies

Staff report

Among the serious dangers that extremely premature infants face are fungal bloodstream infections, and the other treatments they typically receive may make them particularly susceptible to them. Now research conducted by two U.Va. doctors has found that an antifungal antibiotic not previously used on premature babies is effective in preventing the infections.

The doctors, David A. Kaufman and Leigh Grossman Donowitz, published their findings in the Dec. 6 issue of the New England Journal of Medicine
“Fungal infection in premature infants is associated with very high mortality,” said Kaufman, an assistant professor of pediatrics. “We wanted to see if we could prevent this type of infection by giving premature infants the antifungal drug fluconazole.”

For the randomized, controlled trial, Kaufman and Donowitz, professor of pediatrics and chief of the Division of Infectious Diseases gave the drug to 100 premature infants born at 30 weeks or less of gestation and weighing less than 2 pounds. Half the babies received the medication for the first six weeks of life, the time when most of these babies are at extreme risk because of the life-saving treatments they require. The control subjects received a placebo medication.

None of the babies receiving the medication got fungal infections, while 20 percent of those not receiving it developed serious fungal infections, Kaufman said.
“Fungal infections in premature babies are a marker of how sick they are,” Donowitz said. “They receive many therapies, including steroids, antibiotics, surfactant drugs for underdeveloped lungs, ventilators and transfusions. All these things put them at risk for fungal infections.”

Treating the premature infants with this antifungal therapy did not produce any of the side effects that may, in rare instances, occur with fluconazole use, such as liver damage, the researchers said. In addition, the targeted fungi did not develop resistance to the drug during the study.

“Resistance is a key issue and we followed it meticulously, which is one reason we think this study is important and the use of fluconazole safe for this indication,” Kaufman said. “We followed it for each baby for the six weeks and we followed it in the unit over the 30-month study period, and significant resistance did not occur. This may be due to the lower dose and intermittent dosing we used and to the short, six-week period of exposure.”

Donowitz and Kaufman hope to follow this pilot study with another that includes more patients, to determine if using this therapy may also may decrease the death rates of premature infants.