Objective: The objective of this article is to conduct a cost-effectiveness analysis, based on data up to 18-24 months of follow-up, of the use of inhaled nitrogen oxide vs. oxygen, administered to near-term and term infants with severe respiratory failure who were referred for consideration for extracorporeal membrane oxygenation.
Design: The cost-effectiveness analysis was conducted alongside a randomized controlled trial conducted by the Canadian Inhaled Nitric Oxide Study Group for patients with severe respiratory distress.
Setting: Patients were cared for in Canadian regional neonatal intensive care units; follow-up treatment was based on standard care.
Patients: Term and near-term neonates with severe respiratory failure determined by at least two oxygenation indexes (oxygenation index = mean arterial pressure x Fio2/Pao2) >/=25 at least 15 mins apart.
Interventions: Patients were randomized to inhaled nitrogen oxide or oxygen. If conditions deteriorated, they qualified for extracorporeal membrane oxygenation. Not all who qualified received extracorporeal membrane oxygenation. Standard care followed after hospital discharge.
Measurements and main results: Timelines of analysis were from randomization until the follow-up, which occurred between 18 and 24 months after randomization. Costs included those for initial hospitalization (neonatal intensive care, medications, extracorporeal membrane oxygenation, transport) and standard medical services above routine care and developmental services received until follow-up. Outcomes included mortality rate, clinical outcomes, and a variety of neurodevelopmental indicators. Costs were not significantly different between interventions. While infants who received inhaled nitrogen oxide generally did better than those who received oxygen, the only variable that was significant was the number of seizure disorders. On economic grounds, inhaled nitrogen oxide was the preferred intervention.