Inhaled Nitric Oxide (iNO) is an FDA approved drug used both in term and near-term neonates suffering from respiratory failure due to pulmonary hypertension. Despite the fact that the drug does not offer clinical benefit in preterm neonates, iNO is still prescribed for these patients, according to a study of researchers at the Mayo Clinic Children’s Center, now published in the journal Pediatrics.
The National Institute of Child Health and Human Development (NICHD) reported in 2011 that evidence shows no clear benefit of the use of iNO in preterm neonates and also discouraged the use of this treatment. The American Academy of Pediatrics in 2014 stated similar opinions.
“Despite professional guidance from the NICHD to discourage off-label iNO use, neonatologists in many NICUs throughout the United States continue to use this medication in the most premature of neonates,” said lead author Marc Ellsworth, M.D., a neonatology fellow at the Mayo Clinic Children’s Center.
In the study titled “Off-Label Use of Inhaled Nitric Oxide After Release of NIH Consensus Statement” the research team used data obtained from the Pediatrix Medical Group Clinical Data Warehouse to define first exposure iNO use among all neonates admitted and stratified by gestational age.
Results revealed that the rate of iNO utilization in 23- to 29-week neonates increased from 5.03% to 6.19%, between 2009 and 2013. Of all neonates who received iNO therapy in 2013, about half were <34 weeks’ gestation. These infants accounted for more than half of all first exposure iNO days each year of the study period.
Based on the results, the researchers concluded that the rates of off-label iNO use in preterm infants continues to increase in spite of the fact that there is no evident clinical benefit for preterm infants. According to the authors, this pattern of iNO prescriptions comes with economic consequences. In a press release, Dr. Ellsworth further clarified that estimates of off-label use in the United States incurred a cost of $153 million alone in 2013.
“It is important that neonatologists discuss with parents fully the possible risks and benefits of this expensive therapy and how it can best be used in their specific child before it is prescribed,” concluded Dr. Ellsworth.