ACTRN12611000741987招募中未知
Paracetamol Duct Action(PDA) Trial: The effect of paracetamol vs placebo on ductal closure in premature infants with a late patent ductus arterious
A/Professor Martin Kluckow0 个研究点目标入组 60 人开始时间: 2011年7月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 4 Weeks 至 20 Weeks（—）
- 性别
- All
入选标准
- •1.Babies with a persistent PDA born <33 weeks gestational age who are >4 weeks of postnatal age and tolerating at least 50% (i.e. 80ml/kg/day) of enteral feeds
- •2.Echocardiographic findings of a PDA with a Colour Doppler duct size more than 1.5mm with pulsatile pattern with or without oxygen and/or CPAP support.
- •3.Informed written parental consent
排除标准
- •1.PDA with evidence of congestive cardiac failure, signs include tachycardia; venous congestion; high catecholamine levels; and, ultimately, insufficient cardiac output with poor perfusion and end-organ compromise.
- •2.Abnormal liver function tests :
- •a.Elevated alanine transaminase (twice normal level for corrected gestation)
- •b.Elevated aspartate transaminase (twice normal level for corrected gestation)
- •c.Elevated conjugated bilirubin (>80mmol/L)
研究者
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