Prospective Multicenter Registry for Preterm Newborns With Severe Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this prospective research registry is to collect data on treatment strategies and outcomes for premature newborns with severe pulmonary hypertension (PH).
详细描述
There is a lack of consensus on the role of inhaled nitric oxide (iNO) therapy and other pulmonary vasodilators for the treatment of severe pulmonary hypertension (PH) in premature newborns (<34 weeks gestation). However, a proper randomized, controlled trial of iNO in premature newborns with severe PH has not been completed. Some practices embrace the American Academy of Pediatrics (AAP) statement that there is no condition for which iNO should be used in the premature newborn, and others selectively treat premature infants with inhaled nitric oxide (iNO) who suffer life threatening hypoxemia due to suprasystemic PH and right-to-left veno-arterial admixture across the arterial duct and/or oval foramen. The number of neonatal intensive care units (NICUs) adopting each of these approaches is currently unknown, but it is possible that the former group is increasing due to administrative pressure to reduce uncompensated off-label iNO use. A prospective registry collection of treatment strategies and outcomes for this subset of premature newborns will help define current treatment strategies and yield important information about safety and efficacy of the different approaches to management, and would inform the debate more effectively than a series of iNO treated infants alone. Data collected includes maternal age, race/ethnicity, pregnancy and delivery complications, prenatal medications, infant characteristics such as Apgar scores, birthweight, congenital anomalies, respiratory status, pharmacologic therapy used for PH and its side effects, and blood gas data. Up to 100 sites in North America will be invited to monitor for appropriate cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Minutes 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborns 23-34 weeks gestation
- •Echocardiographic evidence showing systemic or suprasystemic levels of PH, or > 5% difference in pre-post ductal saturation if echo is not available.
- •Fraction of inspired oxygen (FiO2) >0.60 in the first 72 hours after birth
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
Occurrence of death
Cause of death
时间窗: From birth through hospital discharge or death, whichever occurs first, assessed up to one year
The cause, if death occurred
次要结局
- Number of Days Hospitalized(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)
- Number of Days on Ventilation(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)
- Patent Ductus Arteriosus (PDA) Ligation(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)
- Development of Necrotizing Enterocolitis (NEC)(From birth through surgical repair of NEC, assessed up to one year)
- Development of Early Bacterial Sepsis(From Birth through 3 days of life)
- Classification of Bronchopulmonary Dysplasia (BPD)(At 36 weeks after birth)
- Pneumothorax(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)
- Development of Late Bacterial Sepsis(From Day 4 of life through hospital discharge or death, whichever occurs first, assessed up to one year)
- Intracranial hemorrhage(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)
- Cystic Periventricular Leukomalacia (PVL)(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)
- Neurological Exam(The most recent exam immediately prior to discharge or death, whichever occurs first, assessed up to one year)
- Surgery for Retinopathy of Prematurity (ROP)(From birth through hospital discharge or death, whichever occurs first, assessed up to one year)