Recipient organisationGreat Ormond Street Hospital for Children NHS Foundation Trust
Funding£205K
PeriodDec 2025 — Nov 2027
In plain English
AI plain-English summary
Every year, hundreds of infants born with heart defects develop a life-threatening gut disease called necrotising enterocolitis (NEC), but doctors struggle to diagnose it accurately in its early stages. The problem is that early NEC looks like many other gut problems in sick newborns. When doctors are unsure, they must stop the baby’s milk feeds and give antibiotics unnecessarily—causing stress for families and delaying recovery. This study tests whether measuring a protein called calprotectin in stool samples can give a clearer, faster answer. Calprotectin leaks into the gut when inflammation starts, so elevated levels could signal NEC before other tests become positive. Researchers will collect stool from 270 infants across four UK children’s hospitals before and after heart surgery, and whenever doctors suspect NEC. They will compare calprotectin levels against the current “gold standard” diagnosis—a combination of symptoms, blood tests, and X-rays. They will also measure the real-world burden of an inconclusive diagnosis: how many days infants go without milk, how many antibiotics they receive, and how long they stay in hospital. If calprotectin proves accurate, it could be added to clinical guidelines as a rapid, non-invasive test. That would reduce diagnostic errors, spare infants from unnecessary treatment, and give parents clearer answers sooner.
View original technical description
Research question: Is faecal calprotectin an accurate diagnostic tool for necrotising enterocolitis (NEC) in infants with heart defects? Background: NEC is a serious type of gut disease that can develop in infants born with cardiac defects, it causes inflammation and injury to the gut mucosa and may be life-threatening. Making an accurate and timely diagnosis of NEC is a significant clinical challenge. In the early stages of the disease, the clinical presentation of NEC is difficult to identify correctly. An inaccurate diagnosis of NEC results in the withdrawal of an infant's milk feed and unnecessary administration of antibiotics, exacerbating parental stress in intensive care. Calprotectin is secreted into the lumen in the early stages of intestinal inflammation, thus elevated faecal calprotectin concentrations are evident in infectious and inflammatory diseases. Aim: Assess the diagnostic performance accuracy of faecal calprotectin to diagnose NEC in infants with cardiac defects. Objectives: 1. Collect faecal samples to measure calprotectin levels before and after cardiac surgery, at the same time, the medical team is suspicious that NEC may develop when using current 'Gold Standard' (clinical features, blood tests and gut X-rays). 2. Assess the clinical burden of an inconclusive suspected NEC diagnosis. Methods. 1: A prospective, multicentre study (Alder Hey, Birmingham, Great Ormond Street and Southampton). Target sample size n=270 infants. Inclusion: Infants who require cardiac surgery or catheterisation for a major congenital heart defect. Primary Outcome: Faecal calprotectin concentrations at a confirmed NEC diagnosis when using the current 'Gold Standard'. All infants recruited to the study will have stool collection (100mg) at baseline (hospital admission), first stool post-surgery and at the time the medical team suspect the presence of NEC the index diagnostic test (faecal calprotectin) will be collected to coincide with the reference test (gold standard). The calprotectin will be measured using the commercially available enzyme-linked immunosorbent assay. Statistical Analysis: The calprotectin measurement collected at the time point when the medical team suspected NEC would be used to produce the Receiver Operating Characteristic (ROC) curves to assess the diagnostic accuracy of faecal calprotectin to distinguish between NEC and no NEC. 2: Infants diagnosed with suspected NEC will undergo a retrospective secondary analysis to explore the clinical burden related to an inconclusive NEC diagnosis. Outcomes measured: number of days nil by mouth, antibiotics administered, biochemistry - C Reactive Protein, Length of hospital stay. Timelines: Total study period: 24 months Anticipated Impact: Future validation study to assess the impact of adding calprotectin to the current NEC diagnostic algorithm to measure the effectiveness of reducing diagnostic error for inconclusive suspected NEC. Update international NEC clinical guidelines with the addition of calprotectin cut-off levels to mitigate an incorrect NEC diagnosis and improve the timeliness and accuracy of making a NEC diagnosis. Dissemination: An end-of-study lay report will be sent to participating families and study results will be presented at international conferences and published in a peer-reviewed journal
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