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Objective: We previously reported improved oxygenation, but no change, in rates of extracorporeal membrane oxygenation (ECMO) use or death among infants with persistent pulmonary hypertension of the newborn who received inhaled nitric oxide (NO) with conventional ventilation, irrespective of lung disease. The goal of our study was to determine whether treatment with inhaled NO improves oxygenation and clinical outcomes in infants with persistent pulmonary hypertension of the newborn and associated lung disease who are ventilated with high-frequency oscillatory ventilation (HFOV)., Design: Single-center, prospective, randomized, controlled trial., Setting: Newborn intensive care unit of a tertiary care teaching hospital., Patients: We studied infants with a gestational age of > or =34 wks who were receiving mechanical ventilatory support and had echocardiographic and clinical evidence of pulmonary hypertension and hypoxemia (PaO2 < or =100 mm Hg on FIO2 = 1.0), despite optimal medical management Infants with congenital heart disease, diaphragmatic hernia, or other major anomalies were excluded., Interventions: The treatment group received inhaled NO, whereas the control group did not. Adjunct therapies and ECMO criteria were the same in the two groups of patients. Investigators and clinicians were not masked as to treatment assignment, and no crossover of patients was permitted., Measurements and Main Results: Primary outcome variables were mortality and use of ECMO. Secondary outcomes included change in oxygenation and duration of mechanical ventilatory support and supplemental oxygen therapy. Forty-two patients were enrolled. Baseline oxygenation and clinical characteristics were similar in the two groups of patients. Infants in the inhaled NO group (n = 21) had improved measures of oxygenation at 15 mins and 1 hr after enrollment compared with infants in the control group (n = 20). Fewer infants in the inhaled NO group compared with the control group were treated with ECMO (14% vs. 55%, respectively; p = .007). Mortality did not differ with treatment assignment., Conclusions: Among infants ventilated by HFOV, those receiving inhaled NO had a reduced need for ECMO. We speculate that HFOV enhances the effectiveness of inhaled NO treatment in infants with persistent pulmonary hypertension of the newborn and associated lung disease.

A retrospective review of all patients cared for who met Loe's criteria for extracorporeal membrane oxygenation (ECMO) was conducted covering the 3-yr period 1983 through 1985. There were five out of 3,726 admissions who met criteria for ECMO (three of 127 outborn admissions). All infants were greater than 2 kg birth weight and met criteria based on alveolar-arterial oxygen pressure difference (P[A-a]O2), barotrauma criteria, or both P(A-a)O2 and barotrauma criteria. All infants had persistent pulmonary hypertension. Two patients also had hyaline membrane disease and one also had asphyxia and meconium aspiration. All patients were treated with conventional therapy and all survived. There were no patients who met criteria for ECMO and died and there were no patients referred for ECMO during this period. Published criteria for ECMO estimate a control group mortality rate of 80% to 94%. Mortality for this series was 0%. (Ninety-five percent confidence interval for mortality in a group of five survivors is 0% to 45%.) Controlled trials of ECMO were not done initially because it was considered unethical. This series shows that historical mortality rates are no longer valid and that controlled trials must be done.