PINO

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。PINO是一项多中心、随机、双盲、对照试验，旨在评价吸入一氧化氮（iNO）治疗继发于呼吸窘迫综合征（RDS）、脓毒症/肺炎、特发性肺动脉高压和/或疑似肺发育不良的呼吸衰竭早产儿的疗效。该试验将干预组（iNO治疗）与对照组（无额外流量）进行比较，并将常规管理策略（如表面活性剂和高频通气）作为iNO治疗的替代品。早产儿严重呼吸衰竭在很大程度上是由于表面活性物质缺乏。虽然外源性表面活性剂的管理可以导致显着改善氧合，高达50%的早产儿有一个次优的反应。有报告称，短期使用吸入性iNO治疗早产儿RDS，总体效果良好。在患有RDS的早产儿中使用iNO的生理学原理取决于其引起选择性肺血管舒张以及改善通气/灌注匹配的能力。主要假设是，与对照组相比，iNO治疗将降低20%的死亡或慢性肺部疾病的发生率，定义为受孕后36周时的补充氧气需求，按出生体重分层。一些次要结局包括严重脑室内出血（IVH）的发生率和18个月龄时的神经发育状况（校正早产）。目前正在对出生体重> 1 500克和妊娠期<34周的婴儿进行试点研究，并将进行单独的数据分析。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PINO is a multicenter, randomized, double-masked, controlled trial developed to evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of preterm infants with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia. The trial compares an intervention group (iNO therapy) to a control group (no additional flow) and otherwise incorporates conventional management strategies such as surfactant and high frequency ventilation as adjuncts to iNO therapy. Severe respiratory failure in the premature infant is due in large part to surfactant deficiency. Although administration of exogenous surfactant can cause dramatic improvements in oxygenation, up to 50% of premature infants have a suboptimal response. There have been reports of the short-term use of inhaled iNO to treat RDS in premature infants with generally positive results. The physiologic rationale for the use of iNO in the premature infant with RDS is dependent on its ability to cause selective pulmonary vasodilation as well as improve ventilation/perfusion matching. The primary hypothesis is that iNO therapy will reduce, by 20%, the incidence of death or chronic lung disease, defined as a supplemental oxygen requirement at 36 weeks post-conceptional age, when compared to the control group, stratified by birth weight. Some of the secondary outcomes include the incidence of severe intraventricular hemorrhage [IVH] and neurodevelopmental status at 18 months of age, corrected for prematurity. A pilot study for infants with birthweights >1,500 grams and <34 weeks gestation is being conducted concurrently and will undergo separate data analysis.