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Diagnostic test accuracy study of methods which identify surgical Necrotising enterocolitis – Surgical NEC Study

Safe People

Organisation name

University Hospital Southampton NHS Foundation Trust

Applicant name(s)

Funders/ Sponsors

Safe Projects

Project ID

SDE_WXS_PROJ_75

Lay summary

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. We want to identify the most effective objective method to identify which babies need surgery earlier than they are identified currently. This will allow earlier surgical treatment saving lives and preventing long term poor health in prematurely born babies. We will do this using a large pre-existing dataset of infants with NEC (n~700) taken from multiple neonatal units across the country. This includes clinical, laboratory, radiograph and vital signs data at high frequency (1 minute intervals for vital signs) from admission to discharge. Infants within the dataset either underwent surgery or had medical treatment alone. The accuracy of each method identified in previous research will be determined using this large dataset to determine which method is most effective.

Public benefit statement

Necrotizing enterocolitis (NEC) is a life-threatening illness almost exclusively affecting neonates with a mortality rate as high as 50 percent. The pathophysiology of NEC is inflammation of the intestine leading to bacterial invasion causing cellular damage and cellular death and necrosis of the colon and intestine. Earlier identification of need for surgery in necrotizing enterocolitis (NEC) has the potential to improve the unfavourable outcomes in this condition.

Other approval committees

Latest approval date

23/01/2024

Safe Data

Dataset(s) name

Surgical NEC

Safe Setting

Access type

TRE

Safe Outputs

Link to research outputs