NECTAR
Research type
Research Study
Full title
An exploratory physiological study of Necrotising Enterocolitis (NEC) Treatment on the plasma Arginine:Asymmetric Dimethylarginine Ratio
IRAS ID
351465
Contact name
Colin Morgan
Contact email
Sponsor organisation
Liverpool Women's Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The NECTAR study will use remaining serum from blood samples that are being taken routinely for their baby’s clinical care to measure levels of two naturally produced chemicals called Arginine and Asymmetric Dimethylarginine or ‘ADMA’, during the diagnosis, treatment and recovery of a gut complication of prematurity called necrotising enterocolitis or 'NEC'. NEC has high morbidity and mortality associated with it and can require an operation as part of the treatment. The infants will undergo routine clinical care throughout the study. No extra blood or additional blood tests will be taken for NECTAR. Surplus serum taken from routine clinical blood tests will be used to measure Arginine and ADMA.
Research has shown that newborn babies do not get enough arginine, especially if they cannot milk feed because of prematurity, NEC or are having an operation on their tummy. A study has shown that babies with NEC with a low arginine and high ADMA had more complications and recovered slower. This study did not look at the Arginine or ADMA levels over the course of their treatment and recovery or if these babies went on to need an operation. We predict Arginine and ADMA can be used to predict which babies go onto require surgery for NEC and those that recover quicker. If these blood levels are useful in predicting recovery from surgery, we may be able to develop treatments in the future that will help recovery mote quickly and reduce complications from NEC.
NECTAR will look at the Arginine and ADMA levels in 40 babies born < 30 weeks gestation being treated for NEC before, during and after their treatment across two sites, the Neonatal Unit at Liverpool Women’s Hospital and the Neonatal Surgical Unit at Alder Hey Children’s Hospital.
Recruitment will take place from April 2025 and run for approximately 18 months.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0082
Date of REC Opinion
9 Apr 2025
REC opinion
Favourable Opinion