NL-OMON24880尚未招募不适用
Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial
Erasmus University Medical Center Rotterdam0 个研究点目标入组 398 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 398
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Admitted to the NICU of one of the participating centres
- •- Written informed consent of both parents or legal representatives
- •- Gestational age at birth < 29 weeks
- •- Caffeine therapy, adequately dosed
- •- Optimal non-invasively supported according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, NIV-NAVA, BIPAP/Duopap, SIPAP)
- •- Apnea that require a medical intervention as judged by the attending physician
排除标准
- •- previous use of open label doxapram
- •- use of theophylline (to replace doxapram)
- •- chromosomal defects (e.g. trisomy 13, 18, or 21)
- •- major congenital malformations that: compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); result in chronic ventilation (e.g. Pierre Robin sequence); increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities); palliative care or treatment limitations because of high risk of impaired outcome
研究者
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