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RecruitingNAINTERVENTIONAL

WithHolding Enteral Feeds Around Blood Transfusion (International)

This important study, called WHEAT International, is investigating the best way to feed very premature babies (born before 30 weeks) when they need a blood transfusion. Many premature babies need blood transfusions, and some later develop a severe gut illness called necrotising enterocolitis (NEC), which can be very serious. Currently, some hospitals pause feeding around transfusions, while others continue feeding as usual. Both approaches are considered safe. This study aims to find out if one of these feeding methods is better at reducing the risk of NEC. Babies in hospitals across Canada and the UK will be randomly assigned to either temporarily stop feeds or continue feeds during their transfusion. We want to see if this makes a difference to their health.

At a glance

Status
Recruiting
Phase
NA
Sponsor
IWK Health Centre
Enrolment target
4,333
Start
28 Jan 2022
Estimated completion
31 Mar 2027

What is this study about?

Necrotising enterocolitis (NEC) is a very serious and sometimes life-threatening gut problem that mostly affects premature babies. It happens when harmful bacteria invade the wall of the baby's intestine, causing inflammation and damage. Even though it's rare, it can lead to severe health problems and even death in very premature babies. Doctors and researchers are actively looking for ways to prevent NEC, as survivors can often face long-term health and developmental challenges.

We know that many premature babies, especially those born very early, need blood transfusions. There's been a suggestion that NEC might sometimes develop after a blood transfusion. Because of this, some doctors wonder if pausing milk feeds for a short time around a transfusion could help reduce the risk of NEC. However, we don't have enough clear evidence yet to say for sure what the best approach is.

This study, called WHEAT International, aims to provide that clear evidence. We want to compare two different ways of feeding premature babies during blood transfusions. One group of babies will have their milk feeds stopped for a few hours before, during, and after their transfusion. Another group will continue to receive their milk feeds as normal throughout the transfusion. Both of these approaches are currently used in hospitals. By comparing them, we hope to learn if one method is more effective at preventing NEC without causing other problems.

Key takeaways

  • The WHEAT study aims to find the best feeding approach for premature babies during blood transfusions.
  • It compares temporarily stopping feeds versus continuing feeds.
  • The goal is to reduce the risk of a serious gut condition called Necrotising Enterocolitis (NEC).
  • Both feeding methods are currently considered safe practice.
  • Participation involves your baby being placed in one of the two feeding groups by chance.
  • There are no extra tests or visits for your baby due to the study.

Who may be eligible?

This study is open to very premature babies born before 30 weeks of pregnancy. They can be of any age from birth up to 30 weeks corrected age. Both boys and girls can take part.

Your baby won't be able to join the study if their parents decide they don't want them to participate. Also, babies who have already had a blood transfusion where they were continuously fed before joining the study might not be eligible. If your baby isn't currently receiving much milk through feeding, or if they have certain serious gut problems that make feeding difficult, they won't be able to take part.

Finally, babies who have already had a serious episode of NEC are not able to join this study, as the aim is to find ways to prevent this condition from happening in the first place.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Was your baby born before 30 weeks of pregnancy?
  2. Has your baby not had a serious gut problem (like NEC) before?
  3. Is your baby currently receiving milk feeds (not just very tiny amounts, or nothing at all)?
  4. Have you not chosen to opt out of the study already?
Answer every question to see your result.

What does participation involve?

If your baby takes part in the study, they will be randomly assigned to one of two feeding groups around the time of their blood transfusion. This means it's decided by chance, like flipping a coin, whether they will temporarily stop feeds or continue feeds. This is the main difference in care within the study. Your baby's doctors will continue to monitor their health as usual. There are no extra hospital visits or special assessments involved directly because of this study. The total duration of participation depends on when your baby needs a transfusion, and their health is typically followed during their stay in the Neonatal Intensive Care Unit (NICU).

Potential risks and benefits

The potential benefit of taking part is that we might find a better way to feed premature babies during transfusions, which could help reduce the risk of NEC for future babies. For your baby, their care will follow one of two standard practices currently used in hospitals. Experts already consider both approaches safe. There are no known additional risks to your baby's health from participating compared to standard care, as both methods are already used. You always have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • IWK Health
    Verified postcode
    Halifax, Canada· Recruiting
  • Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)
    Verified postcode
    Norwich, United Kingdom· Recruiting
  • The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)
    Verified postcode
    Hillingdon, United Kingdom· Recruiting
  • Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)
    Verified postcode
    London, United Kingdom· Recruiting
  • Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)
    Verified postcode
    London, United Kingdom· Recruiting
  • Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)
    Verified postcode
    London, United Kingdom· Recruiting
  • Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)
    Verified postcode
    Luton, United Kingdom· Recruiting
  • East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)
    Verified postcode
    Ashford, United Kingdom· Recruiting
  • Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)
    Verified postcode
    Aylesbury, United Kingdom· Recruiting
  • Barnsley Hospital NHS Foundation Trust
    Verified postcode
    Barnsley, United Kingdom· Recruiting
  • Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What is necrotising enterocolitis (NEC)?

NEC is a serious gut problem that affects premature babies, causing inflammation and damage to their intestines.

Why a blood transfusion for premature babies?

Many premature babies need blood transfusions due to anaemia or other conditions, as their bodies are still developing.

What does 'randomly assigned' mean?

It means your baby will be put into one of the two feeding groups by chance, like drawing numbers from a hat.

Will my baby get extra tests?

No, your baby will not have any extra tests specifically because of this study. Their usual care will continue.

Can I change my mind if my baby joins?

Yes, you can choose to withdraw your baby from the study at any time, and their medical care will not be affected.

How to find out more

Cari-Lee Carnell

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "WithHolding Enteral Feeds Around Blood Transfusion (Internat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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