SAFE-NEC
Research type
Research Study
Full title
Single-test accuracy study to assess the diagnostic value of faecal calprotectin to diagnose necrotising enterocolitis in infants with heart defects
IRAS ID
348799
Contact name
Graeme O'Connor
Contact email
Sponsor organisation
Great Ormond Street Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The aim of our study is to improve doctor's ability to diagnose a serious type of gut disease that can develop in babies born with heart problems. To achieve this aim we plan to measure levels of a special marker found in poo before and after heart surgery to identify if this marker is higher in infants who develop gut disease.
Babies born with a heart problem are also at higher risk of getting gut disease because their heart cannot pump enough blood to the gut. It is difficult for doctors to diagnose this type of gut disease in the early stages but due to the limitation of the current tools to diagnose gut issues. Therefore, some babies are treated for gut disease when they may not have it. This means the baby’s milk feeds are stopped for many days and given antibiotics unnecessarily. Repeatedly stopping the baby's milk feeds means the baby grows slower and increasing parents stress.
We want to measure a special protein marker found in poo to see if tells us the gut is becoming infected. If this special protein marker works, we can make the baby's care more accurate.
To assess if this special marker is higher in babies with gut disease, we will collect poo samples from 300 babies before and after heart surgery. We will also collect a poo sample from babies when doctors think they may have gut disease, after doing the standard tests (blood tests and gut X-rays). The hospital laboratory will measure the amount of this special marker to see if it changes before and after gut disease. This will help us find out if this special marker is linked to gut disease and may help doctors give the correct diagnosis and best treatment to babies.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
25/LO/0888
Date of REC Opinion
8 Jan 2026
REC opinion
Further Information Favourable Opinion