May 06, 2021

 

Inhaled Nitric Oxide Improves Oxygenation in Preterm, Term-Near-Term Neonates With Hypoxic Respiratory Failure

 

By Eric Ramos

 

VIRTUAL -- May 6, 2021 -- Use of inhaled nitric oxide (iNO) in routine clinical practice for improving oxygenation in preterm neonates with pulmonary hypertension-associated with hypoxic respiratory failure is at least as effective as in term-near-term (TNT) neonates, according to a study presented at the 2021 Virtual Annual Meeting of the Pediatric Academic Societies (PAS).

 

The findings, from the PaTTerN study (NCT03132428), are important because efficacy of iNO in preterm neonates with hypoxic respiratory failure/pulmonary hypertension has not been definitely established. In addition, current guidelines state that there is insufficient evidence available to recommend routine use of iNO in preterm infants, although off-label use is common.

 

For the multicentre study, Leif Nelin, MD, Nationwide Children’s Hospital, and The Ohio State University, Columbus, Ohio, and colleagues enrolled 55 preterm neonates (born ≥ 27 to < 34 weeks gestation) and 85 TNT neonates (born at ≥34 to ≤40 weeks gestations) with pulmonary hypertension.

 

The infants were treated with iNO right after birth to 7 days of age for a minimum treatment period of at least 24 hours and up to 96 (± 12) hours as part of routine clinical practice in a Level III or higher neonatal intensive care unit.

 

The primary outcome was the number of neonates with ≥ 25% decrease in oxygenation index (OI) or surrogate OI (SOI).

 

Of the 140 neonates, 51% completed 96 hours of treatment. Of the preterm neonates, 50 (90.9%) achieved a ≥ 25% decrease in OI/SOI, as did 75 (88.2%) of the TNT neonates. Efficacy of iNO to treat hypoxic respiratory failure/pulmonary hypertension in the preterm group was noninferior to the TNT group.

 

Overall, 17 patients experienced a total of 21 adverse events of special interest, including intracranial haemorrhage (preterm, 10 events; TNT, 1 event), air leaks of any type (preterm, 4 events; TNT, 2 events), necrotizing enterocolitis (preterm, 1 event; TNT, 0 events), pulmonary haemorrhage (1 event in each group), and sepsis (preterm, 1 event; TNT, 0 events). None of the events were considered related to treatment.

 

“These registry findings help expand our understanding of a potential role of inhaled nitric oxide therapy in preterm infants with hypoxic respiratory failure with pulmonary hypertension,” said Dr. Nelin.

 

Funding for this study was provided by Mallinckrodt Pharmaceuticals.

 

The PAS meeting is sponsored by the American Academy of Pediatrics, the Society for Pediatric Research, the American Pediatric Society, and the Academic Pediatric Association.

 

[Presentation title: Use of Inhaled Nitric Oxide (iNO) in Preterm (PT) vs Term/Near-Term (TNT) Neonates With Pulmonary Hypertension (PH): Results of the PaTTerN Registry Study. Poster 85]