ACTRN12608000295347已完成未知
Response of premature infants born before 29 weeks gestation to early targeted treatment with indomethacin vs placebo in terms of the combined outcome of mortality/abnormal head ultrasound at nursery discharge.
Martin Kluckow0 个研究点目标入组 370 人开始时间: 2008年6月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 370
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
- 3 Hours 至 12 Hours（—）
- 性别
- All
入选标准
- •Infants born < 29 weeks gestational age
- •Infants < 12 hours old
- •Echocardiogram to assess ductal size able to be performed
排除标准
- •1] Intraventricular haemorrhage grade 3 – 4 at time of initial scan.
- •2] Baby is clinically unstable and not expected to survive.
- •3] Congenital anomalies predicted to influence neurodevelopmental outcome
- •4] Structural heart disease
- •5] R->L shunt - infants with near systemic or suprasystemic pulmonary pressure who may benefit from some RV pressure relief – R>L ductal flow for >33% of cardiac cycle. Rescan in same 12 hour time frame.
- •6] Contraindication to use of indomethacin or ibuprofen (Platelet count <50,000, Creatinine >120 micromol/L, use of NSAID antenatally)
- •7] Unlikely to be able to commence first dose of treatment by 12 hours of age
- •8] Consent not given
研究者
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