EUCTR2010-023988-17-GB进行中（未招募）1 期
Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn. - HIP Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
入选标准
- •Gestational age from 23 weeks at birth to less than 28 completed
- •weeks (i.e. up to and including 27 weeks and 6 days).
- •Within 72 hours of birth.
- •An indwelling arterial line, suitably calibrated and zeroed, to monitor
- •blood pressure with the measuring dome at the level of the mid axillary
- •line when supine.
- •A pre-trial cranial ultrasound scan free of grade III-IV IVH or cystic
- •A mean blood pressure (BP) 1 mmHg or more below a mean BP value
- •equivalent to the GA in completed weeks, which persists over a 15
- •minute period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •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
- •Infant is considered non-viable by attending clinicians.
- •Life-threatening congenital abnormalities including congenital heart
- •disease (excluding patent ductus arteriosus) and chromosomal
- •abnormalities. Infants known to require surgical treatment e.g.
- •congenital diaphragmatic hernia, tracheoesophageal fistula, omphalocele, gastroschisis. Hydrops Fetalis.
- •Parenchymal haemorrhage or a grade III IVH (where over 50% of the ventricle is filled with blood).
研究者
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