Brain Injury in inflammatory disease of the newborn (BIND)
Research type
Research Study
Full title
Surgical Necrotising Enterocolitis - Correlation of immune, inflammatory and genetic markers with brain injury- an observational study
IRAS ID
288645
Contact name
David Edwards
Contact email
Sponsor organisation
Kings College London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Premature babies are at a high risk of inflammatory episodes including infection and necrotising enterocolitis (NEC). NEC may lead to necrosis of gut tissue and perforation requiring surgery. This is associated with poor neurodevelopmental outcomes with higher risk in those who require surgery for NEC (SurgNEC) and have concomitant infection. The mechanism linking SurgNEC with brain injury and subsequent neurodevelopmental outcomes is not fully understood.
The process, type and degree of brain injury in preterm babies related to these illnesses has not been well defined. As highlighted in animal models, a neuroinflammatory response in the neonatal brain secondary to systemic inflammation might be pathological mechanism leading to damage of the developing brain. Detailed MRI can provide information about patterns of brain injury and predict future outcome.
There are variations in severity of brain injury seen with different inflammatory processes. Modelling genetic variation as a variable may allow us to ascertain why different individuals show different susceptibility to brain injury. Understanding the pathomechanisms might help identify early brain-protective interventions.
The aim of this study is to explore the brain injury pattern which occurs in preterm infants with SurgNEC, medical NEC or infection and compare it with healthy preterm and adult controls. We would correlate this further with gut and systemic immune and inflammatory markers. To understand the individual susceptibility and variation of brain injury, genetic analysis will be conducted. This will require gut tissue, saliva and blood samples from the newborn. Healthy adult volunteer (HAV) blood samples will act as a comparator for the immune system analysed in the neonatal blood samples. All infants with NEC and infection will undergo MRI scan at a term equivalent age.
Neonates would be recruited over three-year period from the neonatal unit at Guys and St Thomas Hospital, London.
REC name
London - Fulham Research Ethics Committee
REC reference
20/PR/0964
Date of REC Opinion
5 Feb 2021
REC opinion
Further Information Favourable Opinion