EUCTR2010-023777-19-NL进行中（未招募）1 期
Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants: the SToP-BPD study - SToP-BPD
Academic Medical Center0 个研究点开始时间: 2011年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Preterm infants with a gestational age < 30 wks and/or birth weight < 1250 g, ventilator dependent at 7-14 days PNA with a respiratory index (MAwP x FiO2) of = 3.5. This index should be present for more than 12 h/day for at least 48 hours and must ensure normal oxygen saturation (86-94%) and pCO2 values in premature infants (5.0-7.0 kPa).
- •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
- •Infants with chromosomal defects (e.g. trisomy 13, 18, 21) or major congenital malformations that are expected to compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia) or result in chronic ventilation (e.g. Pierre Robin sequence), or increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations) will be excluded.
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