PINO

皮诺

• 批准号: 7375208
• 负责人: KRISA Page VAN MEURS
• 金额: $ 0.27万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375208
• 关键词: PINO

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。 PINO 是一项多中心、随机、双盲对照试验，旨在评估吸入一氧化氮 (iNO) 治疗因呼吸窘迫综合征 (RDS)、脓毒症/肺炎、特发性肺动脉高压和/或疑似肺发育不全而继发的呼吸衰竭的早产儿的疗效。该试验将干预组（iNO 治疗）与对照组（无额外流量）进行比较，并结合传统的管理策略，例如表面活性剂和高频通气作为 iNO 治疗的辅助手段。早产儿严重呼吸衰竭在很大程度上是由于表面活性剂缺乏所致。尽管给予外源性表面活性剂可以显着改善氧合，但高达 50% 的早产儿反应不佳。有报告称短期使用吸入 iNO 治疗早产儿 RDS 效果普遍良好。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，与按出生体重分层的对照组相比，iNO 疗法可将死亡或慢性肺病（定义为受孕后 36 周补充氧气需求）的发生率降低 20%。一些次要结局包括严重脑室内出血 [IVH] 的发生率和 18 个月大时的神经发育状态（针对早产进行校正）。一项针对出生体重>1,500克且妊娠<34周的婴儿的试点研究正在同时进行，并将进行单独的数据分析。