Mechanisms Affecting Gut of Preterm Infants (MAGPIE)
Research type
Research Study
Full title
Mechanisms Affecting the Gut of Preterm Infants in Enteral feeding trials(MAGPIE)
IRAS ID
180222
Contact name
Nicholas D Embleton
Contact email
Sponsor organisation
Newcastle Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Premature birth is associated with high rates of death, and worse outcomes in survivors. Over the last 20 years, respiratory support has improved meaning more babies now survive. Now, the most common causes of serious illness after the first week are due to gut complications or infections. Necrotising enterocolitis (NEC) is a serious gut disease occurring in premature babies. NEC affects 1 in 10 babies born more than 8 weeks early; 1 in 3 of them require major surgery or die. Infections affect 1 in 5 premature babies, may cause death, and doubles the risk of long term problems such as cerebral palsy. Our group is already undertaking an NIHR funded study (ELFIN) to examine whether the way we feed premature babies affects rates of infection, NEC and brain outcomes: ELFIN - Enteral Lactoferrin in Neonates. That study will tell us whether lactoferrin is a useful treatement for all babies, but it does not tell us how the treatment works. The MAGPIE study (Mechanisms Affecting the Gut of Preterm Infants in Enteral Feeding Studies) will be run alongside ELFIN in a sub-set of babies (around 480 out of the total 2200 babies anticipated to join ELFIN). Babies who have joined ELFIN will be eligible to join the MAGPIE study if they are cared for in a participating hospital. The MAGPIE study simply involves collecting a daily specimen of stool and urine from the baby during hospital stay, and analysing any residual gut tissue if an operation was needed. The samples will be analysed to see if the pattern of gut bacteria affects gut function and will tell us how lactoferrin is working. The samples collected are all non-invasive and pose no additional risk to the baby. They will not affect the conduct of the main ELFIN study or usual medical treatments.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0042
Date of REC Opinion
29 Feb 2016
REC opinion
Favourable Opinion