EUCTR2009-012817-23-FR进行中（未招募）1 期
tilisation d’un surfactant exogène chez des nouveau-nés grands prématurés présentant une détresse respiratoire sévère en prévention de la dysplasie bronchopulmonaire - Etude CURDYS
Maternite Regionale Universitaire de Nancy0 个研究点目标入组 100 人开始时间: 2009年7月10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
- 入组人数
- 100
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
- •Critères d’inclusion : tout nouveau-né d’âge gestationnel inférieur à 33 semaines d’aménorrhée toujours sous ventilation assistée conventionnelle ou par oscillations à hautes fréquences (OHF), après 14+2 jours de vie, avec une FiO2 > 35% et/ou un Index d’Oxygénation (IO= PMA*FiO2 / PaO2) > 8 (PMA = pression moyenne dans les voies aériennes).
- •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
- •infection évolutive (CRP>30mg/l) non maîtrisée par un traitement antibiotique adapté; utilisation de corticoïdes en période postnatale; pathologie neurologique ou malformative remettant en cause la pertinence de l’extubation;intervention chirurgicale < 72 h; refus d’autorisation parentale
研究者
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