NCT07754435尚未招募不适用
Neonatal Laparotomy - A Pilot Randomised Controlled Trial Investigating The Impact of Location of Surgery on Clinical Outcomes and Exploring the Implications For Neonatal, Anaesthetic and Surgical Service Provision
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Death
研究概览
简要总结
This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre.
Outcome will include physiological markers of instability, wound infection, death and others. There will also be a concurrent qualitative workstream exploring the impact of different practices on the wider clinical environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate requiring emergency surgery to the abdomen
- •Parental consent given
- •Clinician agreement for randomisation
排除标准
- •Absolute indication for surgery in particular location
- •No consent given
研究组 & 干预措施
In unit surgery
Active Comparator
Babies will have their surgery performed on the neonatal unit without transfer to a theatre
干预措施: ON unit (Procedure)
Theatre operating
Active Comparator
Babies will be transferred to the operating theatre for surgery
干预措施: IN theatre (Procedure)
结局指标
主要结局
Death
时间窗: Until discharge from hospital from primary episode, around 3-4 months
Survival to discharge
次要结局
- Physiological parameters(During the course of the admission, including the immediate peri-operative period and subsequent recovery phase. Four weeks from surgery)
研究者
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