PiNO Trial Baseline Form (PN03) in Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

PiNO Trial Baseline Form (PN03), SAS. Evaluations at birth.
Study Description
This was a multicenter, randomized, blinded, controlled trial to determine whether inhaled nitric oxide (iNO) reduced the rate of death or bronchopulmonary dysplasia (BPD) in infants. The study included 420 neonates, born at less than 34 weeks of gestation, with a birth weight of 401-1500 grams, and with respiratory failure more than 4 hours after treatment with surfactant to receive placebo (simulated flow) or iNO (5 to 10 ppm). Infants with a response (an increase in the partial pressure of arterial oxygen of more than 10 mm Hg) were weaned. The rate of death or BPD was 80% in the iNO group, as compared with 82% in the placebo group, and the rate of BPD was 60% versus 68%. In conclusion, use of iNO in critically ill premature infants weighing less than 1500 grams does not decrease the rates of death or BPD. Outcomes of surviving infants were assessed at 18 to 22 months corrected age; iNO did not reduce death or neurodevelopmental impairment or improve neurodevelopmental outcomes. Infants with birth weight 401-1500 grams, gestational age < 34 weeks, who were from 4 to 72 hours old, and who required mechanical ventilation

PiNO试验基线表（PN03），采用SAS软件分析，包含出生时的评估项目。
研究概况
本研究为一项多中心、随机、盲法对照临床试验，旨在探讨吸入型一氧化氮（inhaled nitric oxide, iNO）能否降低新生儿死亡或支气管肺发育不良（bronchopulmonary dysplasia, BPD）的发生率。本研究共纳入420名新生儿，均为胎龄小于34周、出生体重401~1500克，且在接受肺表面活性物质治疗后出现呼吸衰竭超过4小时的患儿，按要求分别接受安慰剂（模拟气流）或iNO（5~10ppm）治疗。对出现治疗应答（动脉血氧分压升高超过10mmHg）的患儿逐步撤除治疗方案。iNO组患儿死亡或并发BPD的总体发生率为80%，安慰剂组为82%；其中单独发生BPD的发生率分别为60%与68%。综上，对于体重低于1500克的重症早产患儿，iNO治疗并未降低其死亡或并发BPD的风险。对存活患儿的随访评估于矫正胎龄18~22个月时进行，结果显示iNO并未降低患儿死亡或神经发育障碍的发生率，亦未改善其神经发育结局。出生体重401~1500克、胎龄<34周、出生后4~72小时且需机械通气的新生儿