First RCT evaluates safety, efficacy of furosemide in preemies with BPD risk
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DENVER — The first randomized controlled trial of furosemide for preterm infants at high risk for bronchopulmonary dysplasia found an increased risk for electrolyte adverse events but no greater risk for overall safety events.
Researchers presented the findings during the Pediatric Academic Societies Meeting.
The study found there was no difference in hearing loss, nephrocalcinosis, bronchopulmonary dysplasia (BPD) or death.
Rachel G. Greenberg, MD, MB, MHS, associate professor of pediatrics at the Duke University School of Medicine and member of the Duke Clinical Research Institute, said in a Healio interview that furosemide is the sixth-most common drug used in premature infants in neonatal ICUs.
“There [were] preliminary data or older data, both from animals and from very small studies that looked at short-term benefits to show that furosemide use seems to improve lung mechanics, like lung compliance, and maybe how much respiratory support a baby is requiring,” Greenberg said. “But there [were] no data to show whether it actually helps to prevent the longer term lung disease that we worry about.”
Greenberg and colleagues conducted a randomized, controlled and blinded trial in 17 different health care centers in the U.S., enrolling 80 preterm infants aged younger than 29 weeks’ gestational age to receive either furosemide or a placebo over 28 days. One cohort received the drug once a day, and the second received it four times a day.
A total of 293 adverse events were reported in 74 of the 80 (93%) participants, including 223 among the 56 (92%) infants who received furosemide and 70 among the 18 out of 19 (95%) infants who received placebo (P = 0.94). The most common serum electrolyte adverse events were high bicarbonate levels (73%), hypochloremia (39%) and hyperchloremia (33%).
Greenberg said the next step will be to test this on a larger cohort, and that future furosemide trials should include management of electrolytes as part of the trial design.
“I think it's important to recognize the importance of studying drugs like this in babies in a systematic way to really get the highest quality information,” Greenberg said. “There are data here that we would not have known had we not studied it.”