WHEAT: WithHolding Enteral feeds Around packed red cell Transfusion
Research type
Research Study
Full title
The WHEAT trial: WithHolding Enteral feeding Around packed red cell Transfusions in preterm neonates, a multicentre, superiority, randomised registry trial
IRAS ID
164420
Contact name
Chris Gale
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
The purpose of WHEAT 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 (approximately 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 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 receiving either approach. 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.
Professional opinion (NHS Blood and Transplant, NIHR Children’s Clinical Research Network and most UK neonatal units) supports the need for a trial like WHEAT.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1160
Date of REC Opinion
20 Jan 2015
REC opinion
Further Information Favourable Opinion