NEONATAL INHALED NITRIC OXIDE

新生儿吸入一氧化氮

• 批准号: 6122601
• 负责人: RICHARD A. EHRENKRANZ
• 金额: $ 2.58万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6122601
• 关键词: bacterial pneumonia; clinical research; congenital cardiovascular disorder; hernia; human subject; human therapy evaluation; inhalation drug administration; newborn human (0-6 weeks); nitric oxide; pediatric pharmacology; pulmonary hypertension; respiratory distress syndrome of newborn; respiratory insufficiency /failure; respiratory therapy

Inhaled nitric oxide (INO) will be evaluated as a potential therapy for term and near-term infants with hypoxic respiratory failure including infants with primary persistent pulmonary hypertension of the newborn (PPHN), meconium aspiration, sepsis/pneumonia, respiratory distress syndrome, suspected pulmonary hypoplasia, and congenital diaphragmatic hernia (CDH). Between June 1996 and November 1998, INO was used with all eligible infants in accordance to the recommendations of the Neonatal Inhaled Nitric Oxide Study (NINOS) performed by the NICHD Neonatal Research Network in conjunction with the Canadian Inhaled Nitric Oxide Study Group. In November 1998 eligible patients were enrolled into a similar randomized, controlled trial in which the benefits of early INO would be evaluated in infants with moderate respiratory failure. Infants who presented with severe respiratory failure would receive open lable INO treatment under the same IND. (This is a NICHD Neonatal Research Network Trial.)

吸入型一氧化氮(INO)将被评估为治疗足月儿和近月儿缺氧性呼吸衰竭的潜在疗法，包括新生儿原发性持续性肺动脉高压(PPHN)、胎粪吸入、败血症/肺炎、呼吸窘迫综合征、疑似肺发育不良和先天性横隔疝(CDH)。1996年6月至1998年11月，根据NICHD新生儿研究网络与加拿大吸入一氧化氮研究小组联合进行的新生儿吸入性一氧化氮研究(NINOS)的建议，对所有符合条件的婴儿使用了INO。1998年11月，符合条件的患者被纳入一项类似的随机对照试验，在该试验中，将评估早期INO对中度呼吸衰竭婴儿的益处。出现严重呼吸衰竭的婴儿将在相同的IND下接受开放标签INO治疗。(这是NICHD新生儿研究网络试验。)