EUCTR2010-023777-19-BE进行中（未招募）不适用
Systemic Hydrocortisone to Prevent Bronchopulmonary Dysplasia in Preterm INfants: the SToP-BPD Study. - SToP-BPD Study
Z Brussel0 个研究点目标入组 400 人开始时间: 2011年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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 dependency at 7-14 days postnatal age, a respiratory index (RI = MAwP x FiO2) of = 3.5 for more than 12 h/day for at least 48 hours, ensuring adequate oxygen saturation (85-95%) and pCO2 values in premature infants (5.0-7.5 kPa).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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 compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia), 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.
- •Also infants who received dexamethasone or hydrocortisone for the sole purpose of improving lung function and respiratory status prior to inclusion, will be excluded.
研究者
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