Background and study aims
The aim of this study is to compare two practices that are widely used in neonatal units across the UK and around the world to see if one reduces the risk of necrotising enterocolitis (NEC) in babies born early (premature). NEC is a serious gut disease that affects about 1 in 20 very premature babies (about 500 each year). About 1 in 3 of these babies will die of NEC and survivors often have long-term health and developmental problems. In 2014 prevention of NEC was ranked the third most important research priority by parents and perinatal health professionals. Premature babies receive frequent milk feeds (every 1-3 hours) and they often need blood transfusions because they become anaemic (they do not have enough red blood cells). Some doctors worry that feeding babies during a blood transfusion may increase the risk of NEC. Others, however, think that it is more dangerous to stop feeds. Because of this, the way babies are cared for during blood transfusions varies across the country; some babies have milk feeds stopped before, during and after a transfusion (around 12 hours in total) while others have feeds continued. The aim of this study is to determine which approach is best.
Who can participate?
Premature babies (gestational age at birth less than 30 weeks)
What does the study involve?
Babies are recruited shortly after birth (and therefore before they are scheduled to have a blood transfusion in most cases). Blood transfusion is almost universal in babies of this gestational age (90-95% need at least one blood transfusion). The babies are randomly allocated to either have feeds stopped or to have feeds continued for 4 hours before, during and for 4 hours after blood transfusions. The trial uses information that is recorded by doctors and nurses in a baby’s existing electronic health record, rather than collecting it all over again; this makes the trial much simpler and easier. Because this is a new way of collecting information, this 'point of care' approach is tested in a “pilot trial” which is a smaller, shorter “test” trial.
What are the possible benefits and risks of participating?
Both of the feeding approaches are currently acceptable to doctors but it is not known if one is safer. For babies not taking part in this study, it depends on the unit looking after the baby as to whether feeds are given or withheld around blood transfusions. Taking part in the study may be beneficial for the baby. No risks are anticipated.
Where is the study run from?
1. Chelsea and Westminster Hospital (UK)
2. West Middlesex University Hospital (UK)
3. Hillingdon Hospital (UK)
4. Northwick Park Hospital (UK)
5. St Mary's Hospital (UK)
6. Queen Charlotte's and Chelsea Hospital (UK)
7. Birmingham Heartlands Hospital (UK)
8. Good Hope Hospital (UK)
9. Birmingham Women's Hospital (UK)
10. Birmingham Children's Hospital (UK)
11. Birmingham City Hospital (UK)
12. University Hospital Coventry (UK)
13. Princess Royal Hospital (UK)
14. Walsall Manor Hospital (UK)
15. Leicester Royal Infirmary (UK)
16. Hereford County Hospital (UK)
17. New Cross Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2018 to November 2019
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
1. Mrs Kayleigh Stanbury
2. Dr Chris Gale