The WHEAT International Trial: WithHolding Enteral feeds Around red cell Transfusion to prevent necrotizing enterocolitis in preterm neonates: an international, multi-centre, randomized controlled trial.

WHEAT stands for Witholding Enteral feeds Around packed red cell Transfusion to prevent necrotizing enterocolitis in preterm neonates. It is an international, multi-centre, randomized controlled trial that will examine whether withholding milk feeds before, during and after blood transfusion in preterm infants reduces the risk of necrotizing enterocolitis (NEC). 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 often need blood transfusions because they become anemic (not enough red blood cells). Some doctors worry that feeding babies during a blood transfusion may increase the risk of NEC but others think that it is more dangerous to stop feeds. Feeding approaches around blood transfusions therefore vary between sites and different professionals. The purpose of WHEAT is to determine which approach is best by comparing two groups of babies randomly chosen by computer to either have milk feeds stopped or continued around blood transfusions. WHEAT will compare standard practices and involves nothing new or additional to standard care. We aim to enrol over 4,000 babies and will collaborate with co-applicants undertaking an identical study in Australia to identify the best approach. Preventing necrotizing enterocolitis has been identified by parents, patients and 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 NEC, 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 be harmful. A clinical trial like WHEAT is the only way to resolve this uncertainty.