A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure.

作者: G Ganesh Konduri , Alfonso Solimano , Gregory M Sokol , Joel Singer , Richard A Ehrenkranz

DOI: 10.1542/PEDS.113.3.559

关键词: AnesthesiaMedicineRespiratory failureExtracorporeal membrane oxygenationMulticenter trialOxygenationOxygenation indexRespiratory diseasePulmonary hypertensionRandomized controlled trial

摘要: Objective. Inhaled nitric oxide (iNO) reduces the use of extracorporeal membrane oxygenation (ECMO)/incidence death in term and near-term neonates with severe hypoxic respiratory failure. We conducted a randomized, double masked, multicenter trial to determine whether administration iNO earlier failure results additional reduction incidence these outcomes. Methods. Neonates who were born at ≥34 weeks’ gestation enrolled when they required assisted ventilation had an index (OI) ≥15 Results. The enrollment was halted after 75% target sample size reached because decreasing availability eligible patients. 150 infants given early 149 control similar baseline characteristics. Arterial oxygen tension increased by >20 mm Hg 73% 37% study gas initiation. Control received standard deteriorated OI >40 more often than iNO. (early iNO, 6.7% vs control, 9.4%), ECMO (10.7% 12.1%), their combined (16.7% 19.5%) both groups. Conclusion. improves but does not reduce ECMO/mortality initiated 15 25 compared initiation >25

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