The WHEAT pilot trial

Wheat Trial

WHEAT stands for WithHolding 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.

Aim

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, please see the video below for more information.
2. To see whether withholding milk feeds before, during and after blood transfusion in preterm infants reduces the risk of necrotising enterocolitis.

Research Overview

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, they 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 transfusion. Whether feeds will be stopped or continued will be decided by randomisation. Randomisation is done by computer and ensure s that each baby has an equal chance of either having feeds stopped or continued. WHEAT will compare standard UK practices and involves nothing new.

Trial Information

REC Reference:

18/LO/0900

ISRCTN:

62501859

Clinical Trials Unit:

National Perinatal Epidemiology Unit CTU

Sponsor:

Imperial College London & Imperial College Healthcare NHS Trust

Funder:

Medical Research Council

Recruitment Target:

250 estimated target

Duration of Study:

April 2018 - November 2019

This work is supported by the Medical Research Council (MR/N005405/1).

For more information please visit http://neoepoch.com/wheat-trial/

Contact Details

If you would like to contact the trial team, please email ctu@npeu.ox.ac.uk.