Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 385
- 试验地点
- 13
- 主要终点
- Death
研究概览
简要总结
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.
详细描述
The optimal approach to the treatment of PPHN remains controversial. In 1978, hyperventilation was advocated for the treatment of PPHN. Newer therapies such as alkali infusion have been introduced without the support of randomized trial. In addition, in 1993, large controlled trials of inhaled nitric oxide were in the planning stages. There is a lack of knowledge about how these diverse management styles impact patient outcome.
Given the large number of treatments used in neonates with PPHN, we wished to document treatment of PPHN and outcomes of those treatments. Therefore, we performed a prospective, observational study to document prevalence of PPHN, the treatments and outcomes in a large population of infants treated at the 12 centers of the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Further, we sought to compare treatment with hyperventilation to treatment with alkali infusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 34 weeks gestational age
- •On mechanical ventilation and/or fraction of inspired oxygen >0.50; and
- •Had documented pulmonary artery hypertension as defined by either two-dimensional echocardiographic evidence of elevated pulmonary pressure (judged by right to left or bidirectional shunt), or a preductal to postductal oxygen gradient >20 mm Hg
排除标准
- •>7 days of age
结局指标
主要结局
Death
时间窗: 120 days of age
次要结局
未报告次要终点