Inhaled Nitric Oxide (iNO) remains the standard therapy for severe respiratory failure due to pulmonary hypertension in preterm neonates. These are the findings based on a recent study entitled “Off-Label Use of Inhaled Nitric Oxide After Release of NIH Consensus Statement” that was published in the journal Pediatrics by Marc A. Ellsworth, from the Division of Neonatal Medicine, Mayo Clinic, Rochester, Minnesota, USA, and colleagues.
Inhaled nitric oxide (iNO) therapy is an off-label medication for infants younger than 34 weeks of gestational age. iNO is frequently used in term and near-term neonates with pulmonary hypertension approved by the Food and Drug Administration. Over the last ten years, several studies have been trying to establish the clinical use of iNO in preterm neonates. Although iNO has been shown to have short-term benefit, improved long-term outcomes in preemies have not been determined.
In 2011, the National Institute of Child Health and Human Development (NICHD) announced a report discouraging regular iNO usage of this expensive therapy in preterm neonates. Also in 2014, the American Academy of Pediatrics released a report with similar declarations. The main aim of this study was to establish the patterns of iNO usage in American NICUs within the years the NICHD report. The research team hypothesized that iNO prescription rates in premature infants stayed constant since 2011 using the data collected by Pediatrix Medical Group, a division of MEDNAX National Medical Group.
“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 Dr. Ellsworth in the news release.
In the population-based study, the researchers found that between 2009 and 2013, the rate of iNO utilization in 23-29 week neonates had a relative increase of 23%. In 2013, among the neonates that were treated with iNO therapy, almost 50% were younger than 34 weeks of gestation.
Dr. Ellsworth said that over the last four years off-label iNO use in American NICUs has been increasing, lending a significant economic impact with an overall cost of $153 million 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.