Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide Via Invasive or Noninvasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 140
- 试验地点
- 30
- 主要终点
- Number of neonates with significant response to INOmax treatment within each age group
研究概览
简要总结
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through.
Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 27 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Was either a P neonate born at least 27 weeks to less than 34 weeks of gestational age (GA) or a TNT neonate born at least 34 weeks but no more than 40 weeks of GA.
- •Was administered INOmax therapy after birth to 7 days of age via any route (invasive or noninvasive ventilation) for a minimum treatment period of at least 24 hours up to 96 ± 12 hours. The participants may receive INOmax for a longer period.
- •Had PH, as confirmed by echocardiogram or a differential saturation gradient of at least 10%.
- •Received INOmax administration as part of routine clinical practice in a Level III or higher neonatal intensive care unit in the United States.
- •Has all variables required to calculate OI or SOI (a baseline sample prior to treatment and 4 samples obtained during treatment).
排除标准
- •Was at risk of imminent death (death expected within 24 hours).
- •Received extracorporeal membrane oxygenation (ECMO).
- •Had a life-threatening abnormality (cranial, cardiac, thoracic), chromosomal abnormality, congenital diaphragmatic hernia, congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
- •Had been resuscitated requiring chest compressions within 6 hours of receiving INOmax.
- •Had Grade IV bilateral intraventricular hemorrhage or periventricular leukomalacia.
- •Had active uncontrolled bleeding.
- •Had disseminated intravascular coagulopathy.
- •Had active seizures while receiving anticonvulsants.
- •Experienced prolonged asphyxia with evidence of severe acidosis (pH < 7.25).
- •Received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil) except when sildenafil was used to wean the participant from INOmax therapy.
研究组 & 干预措施
P Neonates
Premature (P) neonates [at least 27 weeks but less than 34 weeks of gestational age]
干预措施: INOmax (Drug)
TNT Neonates
Term-Near-Term (TNT) neonates at least 34 weeks of gestational age
干预措施: INOmax (Drug)
结局指标
主要结局
Number of neonates with significant response to INOmax treatment within each age group
时间窗: within 108 hours
Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment
次要结局
- Number of neonates with significant response to Inomax treatment within each age group and severity group(within 108 hours)
- Time to reach significant response to Inomax treatment within each age group and severity group(within 108 hours)
- Number of neonates with partial response to INOmax treatment within each age group and severity group(within 108 hours)