Immunothrombosis in neonates with Necrotizing Enterocolitis (NEC)
Research type
Research Study
Full title
The role of Immunothrombosis and Neutrophil Extracellular Traps (NETosis) in premature neonates with Necrotizing Enterocolitis (NEC): a pilot study
IRAS ID
231503
Contact name
STEFANO GIULIANI
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Necrotizing Enterocolitis (NEC) remains one of the most devastating and poorly understood diseases of premature neonates. It causes a severe and diffuse infection, where portions of the intestine receive less blood and the bowel die without oxygen. About 40-50% of the neonates with NEC become extremely sick and they need major abdominal surgeries. The overall mortality is 30-50% and there are significant long term problems caused by NEC.
There is currently poor knowledge on the changes in the coagulation system (blood clotting) of neonates affected by NEC. Recent findings from our research group showed that neonates with NEC have the tendency to form clots in the blood vessels of their intestine leading to bowel death. In particular, we have found specific alteration in genes expression associated to high deposition of infammatory cells and clots in the blood vessels.
We would like to test the hypothesis that the severe inflammation present in the intestine of babies with NEC can activate the 'immunothrombosis' and lead to reduced blood flow to the intestine and death.
This Pilot Study aims to review the samples of the intestine removed from babies operated for NEC and to compare them with intestinal samples of babies without NEC. We want to see if there are anomalies in the proteins involved in the 'immunothrombosis' that can be targeted for future treatments.
In addition we will study the presence of specific biomarkers of immunothtombosis in the blood of babies with NEC at different stages of disease. This will give us insight on how the biomarkers are changing during the disease progression to be able to predict and stop disease progression in the future. The results from this study will give us the opportunity to develop an interventional clinical trial aiming to reduce disease progression and death in NEC.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0276
Date of REC Opinion
6 Mar 2018
REC opinion
Unfavourable Opinion