WHEAT

• Research type

  Research Study

• Full title

  WithHolding Enteral Feeds Around Blood Transfusion (WHEAT International Trial)

• IRAS ID

  309894

• Contact name

  Chris Gale

• Contact email

  christopher.gale@imperial.ac.uk

• Clinicaltrials.gov Identifier

  NCT05213806

• Duration of Study in the UK

  3 years, 6 months, 30 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. Prevention of NEC was ranked the third most important research priority in preterm birth 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.

  The WHEAT trial will use the information that is recorded by doctors and nurses in a baby’s existing electronic health record, rather than collecting it all over again; this will make the trial much simpler and easier.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  22/LO/0360

• Date of REC Opinion

  16 Jun 2022

• REC opinion

  Favourable Opinion