Objectives: To assess the safety- efficacy balance of low- dose inhaled nit ric oxide (iNO) in hypoxemic premature infants because no sustained beneficial e ffect has been demonstrated clearly and there are concerns about side effects. S tudy design: Eight hundred and sixty infants 40% , and arterio- alveolar ratio in oxygen (aAO2) < 0.22. The primary end point was intact survival at 28 days of age. Results: Sixt y- one of 415 infants presented with HRF and were compared with 84 of 445 contr ols who presented with HRF. There was no difference in the primary end point (61 .4% in infants [23% with HRF who were treated with iNO] vs 61.1% in contro ls [21.4% in controls with HRF]; P =. 943). For the infants with HRF who were treated with iNO, there was no significant difference from controls for intraven tricular hemorrhage (IVH) (6% vs 7% ), necrotizing enterocolitis (8% vs 6 % ), or patent ductus arteriosus (PDA) (34% vs 37% ). Compared with nonhypoxem ic infants, the risk of bronchopulmonary displasia (BPD) increased significantly in HRF controls (OR = 3.264 [CI 1.461- 7.292]) but not in infants with HRF who were treated with iNO (OR = 1.626 [CI 0.633- 4.178]). Conclusions: iNO appears to be safe in premature infants but did not lead to a significant improvement i n intact survival on day 28.
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