EUCTR2007-005513-18-IT进行中（未招募）不适用
Double blind randomized controlled study on the benefit-risk profile of in the treatment of at term or late preterm newborn infants with severe respiratory disorders and pulmonary hypertension - SILDENAFIL AND PULMONARY HYPERTENSION OF NEWBORNS
OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA0 个研究点开始时间: 2008年1月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •neonates ≥34 weeks of gestational age hospitalized in neonatal intensive care units (NICU) within the first week of life with acute respiratory failure of any origin, who require mechanical ventilation, either conventional (tidal) or high frequency oscillatory (HFOV), with an OI ≥10 and echocardiographic evidence of PH.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •major malformation, genetic/chromosomic anomalies incompatible with life or with increased risk of unfavorable neurological outcome, systemic hypotension (mean arterial blood pressure <2 SD the average value for birth weight [8], intracranial hemorrhage, previous iNO exposure.
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