A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.
Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.
BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.
“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”
Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.
For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.
Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.
“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”
The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.
“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.
“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.”
Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.
The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.
The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.
“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”
Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.