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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Chris
Gale
christopher.gale@imperial.ac.uk
Joe
Montebello
wheat@imperial.ac.uk
Sokol
Shala
sokol.shala@nihr.ac.uk
Joe
Montebello
wheat@imperial.ac.uk
Dr
Chris
Gale
christopher.gale@imperial.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Digestive system disorders of fetus and newbornDisorders related to length of gestation and fetal growth
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Management of Care;
You can take part if:
You may not be able to take part if:
1.Packed red cell transfusion with concurrent enteral feeds prior to enrolment (infants who have received a packed red cell transfusion while nil by mouth or receiving minimal enteral nutrition defined as < 15ml/kg/day ARE still eligible) 2.Infants where enteral feeding is contraindicated in the first 7 days after birth (e.g. congenital abnormalities) 3. Parent(s) opt out of trial participation 4. Previous episode of NEC or SIP prior to first packed cell transfusion.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Joe
Montebello
wheat@imperial.ac.uk
Joe
Montebello
wheat@imperial.ac.uk
Dr
Chris
Gale
christopher.gale@imperial.ac.uk
Sokol
Shala
sokol.shala@nihr.ac.uk
Dr
Chris
Gale
christopher.gale@imperial.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by Canadian Institutes of Health Research .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 52933
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
