NCT00431418已完成3 期
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
Mercy Hospital for Women, Australia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Length of ventilation
研究概览
简要总结
The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Newborn babies born <28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life.
排除标准
- •Congenital heart defects
- •Suspected inborn error of metabolism
- •Inhaled Nitric Oxide treatment during assessment
研究组 & 干预措施
1
Active Comparator
Sildenafil oral solution.
干预措施: Sildenafil (Drug)
2
Placebo Comparator
Placebo oral solution.
干预措施: Placebo (Drug)
结局指标
主要结局
Length of ventilation
时间窗: 12 months after completion of study
次要结局
- Bronchopulmonary Dysplasia (BPD)(12 months after completion of study)
研究者
Dr. Kai Konig
Consultant Neonatologist
Mercy Hospital for Women, Australia
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study of Sildenafil to Treat Newborns With Persistent Pulmonary HypertensionPersistent Pulmonary HypertensionRespiratory FailureNCT01409031University of Colorado, Denver3
已完成
1 期
Pharmacokinetics of Sildenafil in Premature InfantsPersistent Pulmonary Hypertension of the NewbornNCT01670136University of North Carolina, Chapel Hill34
Unknown
2 期
Sildenafil and Uteroplacental PerfusionFetal Growth RetardationNCT01107782Tehran University of Medical Sciences70
已完成
2 期
PK Study of Sildenafil in NeonateNeonates and Preterm InfantsNCT02244528Seoul National University Hospital20
终止
2 期
Sildenafil Citrate for the Treatment of Established Pre-EclampsiaPre-eclampsiaNCT00141310Pfizer's Upjohn has merged with Mylan to form Viatris Inc.76