WHEAT stands for Witholding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates. It is a multi-centre, randomised point of care trial. This means that WHEAT uses information that is already being collected by doctors and nurses as part of day to day care, which makes it much simpler and easier to take part in.
There are two aims of WHEAT:
1. To demonstrate that a point of care trial design is a simpler, easier and more efficient way to carry out clinical trials.
2. To see whether withholding milk feeds before, during and after blood transfusion in preterm infants reduces the risk of necrotising enterocolitis.
Necrotising enterocolitis (NEC) is a serious gut disease that affects about 1 in 20 very premature babies; about 1 in 3 will die of the disease and survivors are at high risk of long-term health and developmental problems.
Premature babies receive frequent 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 a blood transfusion varies across the country; some babies have feeds stopped before, during and after a transfusion (around 12 hours in total), and others have feeds continued.
The purpose of WHEAT is to determine which approach is best. We will do this by comparing babies who have feeds stopped with those who have feeds continued during blood transfusions. Whether feeds will be stopped or continued will be decided by randomisation. Randomisation is done by computer and ensures that each baby has an equal chance of either having feeds stopped or continued. WHEAT will compare standard UK practices and involves nothing new. WHEAT will take place in neonatal units all over the UK and will involve about 4,500 babies.
Preventing necrotising enterocolitis has been identified by parents, patients and health professionals as the third most important research priority in the field of preterm birth. If simply stopping feeds when giving a blood transfusion can reduce the risk of necrotising enterocolitis, we could quickly and easily start to prevent this devastating disease. On the other hand, because breast milk has so many beneficial effects for premature babies, stopping it might not be a good idea either. The only way we can resolve this uncertainty is through a clinical trial like WHEAT.
the importance of point of care trials
The other key aim of WHEAT is to show that neonatal point of care trials are feasible and efficient. If we can show this, it will make neonatal research simpler and easier and enable more high quality neonatal clinical trials. This in turn should lead to better care for babies that require neonatal care. In this video Chris and Neena describe point of care trials and explain how supportive the neonatal community in the United Kingdom is.
the wheat trial is now recruiting
The WHEAT trial is initially running in neonatal units in Northwest London and around Birmingham, and we have now started recruiting babies into the trial. For more information about the trial please go the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU-CTU) website www.npeu.ox.ac.uk/wheat