Surgical Decision Making in Necrotising Enterocolitis - a Prospective Qualitative Study of Surgeons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Necrotising enterocolitis (NEC) is a devastating disease which causes severe bowel inflammation resulting in babies becoming critically unwell. It mainly affects premature babies (who can be born as early as 22 weeks) in the first few weeks of life. A quarter of babies don't respond to intensive care treatment and require surgery to remove bowel which has died to prevent them from getting sicker. Sadly, about a third of the most unwell babies don't survive and those that do have a high incidence of significant long-term health problems.
Deciding which babies will benefit from surgery is challenging and there are no objective methods used to do this currently. Surgeons must weigh up the risks and benefits of performing major surgery on a tiny baby in the knowledge that surgery itself may cause harm. This uncertainty causes delays in performing surgery. Those that have a delay are more likely to have a poor outcome.
In order to improve these unfavourable outcomes it is essential to understand and define current practice in detail (i.e. indications and timing for surgery) and understand how this may be associated with outcome. These outcomes are both short term, including mortality and ability to tolerate enteral nutrition, and long term which include neurodevelopmental outcomes at 2 years of life.
To do this the investigators will undertake a multicentre mixed methods study with qualitative interview of consultant paediatric surgeons shortly after making a decision to operate, or not, on a baby with NEC. The investigators will then take consent from the parents/guardian of the infant to follow-up their clinical outcomes using data linkage to routinely collected data, within the national neonatal research database. Outcomes of interest include survival, feeding outcomes, further surgical procedures and neurodevelopment at 2 years.
详细描述
Necrotising enterocolitis (NEC) predominately affects pre-term infants and consists of a severe bowel inflammation which can lead to necrosis. The number of babies at highest risk of developing NEC is rising as survival of extremely preterm babies improves. Whilst unanswered questions remain regarding the aetiology of NEC, the clinical presentation is that of an acutely unwell baby, with abdominal distension requiring intensive care support due to activation of a systemic inflammatory response.
About a quarter of babies will require surgery due to bowel perforation, suspected necrotic bowel or failure to improve with intensive care treatment alone. Most commonly, ischaemic, non-viable gut is found at laparotomy and hence removed. In 1-in-20 surgical procedures the extent of the non-viable gut is so great that survival is not possible.
Surgical practice, including decision-making, in NEC has been previously shown to vary from surgeon to surgeon with no set criteria for when an infant is no longer responding to medical treatment and should have surgery. It can be particularly challenging given that babies with the disease are of extreme prematurity and some weigh as little as 500 grams. There is a real risk of causing harm during surgery hence it is essential that the benefits outweigh the risk. Unfortunately short and long-term outcomes for surgical NEC are poor including mortality in 35% following surgery and 59% of survivors experience neurodevelopmental problems. Recent evidence suggests that earlier surgery for NEC is beneficial and is associated with better outcomes than delayed surgery. Additionally, 20% of neonates with NEC die before surgery which is potentially avoidable with more effective identification of the need for surgery.
In order to improve these unfavourable outcomes it is essential to understand and define current practice in detail (i.e. indications and timing for surgery) and understand how this may be associated with outcome. These outcomes are both short term, including mortality and ability to tolerate enteral nutrition, and long term which include neurodevelopmental outcomes at 2 years of life.
This prospective mixed methods study is entirely observation and involves no intervention. Inclusion in the study is on the basis of fully informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant with suspected or confirmed NEC undergoing review by surgeon, regardless of outcome of that review (I.e. surgery indicated or not).
排除标准
- •Lack of consent from surgeon to undertake interview.
- •Lack of consent from parents to follow-up outcomes of infant.
结局指标
主要结局
Mortality
时间窗: At 52 weeks corrected gestational age and at 2 years age.
Mortality
次要结局
- Death or parental nutrition dependence(Hospital discharge (up to 52 weeks corrected gestational age))