NECrotising enterocolitis GUt Analysis for Risk Detection - NECGUARD
Research type
Research Study
Full title
Phenotypical profiling of gut health in very preterm infants developing necrotising enterocolitis using a multi-modal approach of clinical, physiological, and molecular data
IRAS ID
337022
Contact name
Jayanta Banerjee
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Every year in the UK around 100,000 newborn infants get admitted to the neonatal units, a large proportion of them require admission in neonatal intensive care unit (NICU). These infants include very preterm (VPT) babies, those who are born between 23 and 32 weeks of post-conceptional age. Necrotising enterocolitis (NEC) is a complex condition of the gut seen predominantly in VPT babies. NEC affects around 6% of VPT babies, and more than 10% of extremely preterm (EPT) babies; a third of those affected require surgery, and about 50% of those who require surgery die. Those who survive surgery will end up with a stoma and therefore will require parenteral nutrition for a prolonged period through central lines. It is also well known that NEC significantly increases the risk of cerebral palsy. Parents, researchers, and clinicians worldwide have rated NEC as one of the top three priorities for neonatal research. Phenotypical profiling of the VPT infants will enable early detection and risk stratification of at-risk NEC babies, and it can guide the efficacy of therapeutic interventions in the future. Ultimately, the aim is to demonstrate that that high throughput multi-omics technologies such as this can reduce the mortality and devastating morbidity associated with NEC. In this NECGUARD study we will examine the proposed mechanisms leading to development of NEC using some additional measurements performed non-invasively, such as brain and gut tissue oxygen levels using Near infra-red spectroscopy (NIRS) using a INVOS 7100 NIRS machine, ultrasound scan of the gut and metagenomic and metabolomics of stool samples from the nappies of the babies during their stay in the neonatal unit. The study will run for a period of 3 years and will recruit 425 patients to the study.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0259
Date of REC Opinion
15 Jan 2026
REC opinion
Further Information Favourable Opinion