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An intensive care unit randomised trial - comparing two approaches to providing nutrition during critical illness

This study is for people in intensive care who need help breathing. Normally, these patients get continuous liquid food through a tube. This study wants to see if giving this food only during the daytime (8 am to 10 pm) could be better. The idea is that eating during the day might help reset the body's natural sleep-wake cycle, which could reduce confusion (delirium), a common problem in very sick patients. All participants will get the same amount of food and the same high level of care. We are looking for adults who are admitted to intensive care unexpectedly and require a breathing machine. This project aims to understand if this new feeding approach could have benefits for future patients.

At a glance

Status
Recruiting
Sponsor
University Hospitals Plymouth NHS Trust
Enrolment target
40
Start
03 Nov 2025
Estimated completion
30 Nov 2026

What is this study about?

When you're very poorly and in intensive care, especially if you need a machine to help you breathe, a common problem can be feeling confused or disoriented. Doctors call this 'delirium'. We know that a normal body clock, with clear daytime and nighttime patterns, is important for our health and can help prevent this confusion. In intensive care, patients usually receive liquid food continuously through a tube, day and night.

This study wants to explore whether changing the time of feeding could help reset the body's natural rhythms. We're looking at giving patients their food only during the day, between 8 am and 10 pm. The aim is to see if this daytime-only feeding can support a healthier sleep-wake cycle and lead to less delirium.

It's important to know that if you join, you'll still get all the food your body needs; it will just be given over a shorter period. All patients in the study will continue to receive the best possible care from the intensive care team, just as they would if they weren't part of the research.

Key takeaways

  • The study explores how feeding times affect confusion (delirium) in very sick intensive care patients.
  • Some patients will receive tube feeding only during the day, instead of continuously.
  • This might help reset the body's natural sleep-wake cycle.
  • All participants receive the same amount of food and standard high-quality care.
  • The aim is to find ways to reduce delirium for future patients.

Who may be eligible?

This study is looking for adults aged 18 or over who have had an unexpected admission to intensive care and need a breathing machine. You would also need to be starting or already receiving liquid food through a tube (enteral feeding) and likely to need it for more than two days.

There are some reasons why you wouldn't be able to join. For example, if you were admitted to intensive care on purpose for a planned surgery (unless you needed the breathing machine unexpectedly in the first 24 hours). You also can't take part if you've already been receiving tube feeding overnight before being asked about the study, or if you have certain health conditions like severe diabetes, very low salt levels in your blood, or conditions like dementia.

Additionally, if you're pregnant or breastfeeding, or if your doctor thinks daytime-only feeding wouldn't be safe or suitable for you, then you wouldn't be able to join this study.

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. Are you an adult (18 or older)?
  2. Did you come into intensive care unexpectedly?
  3. Do you need a breathing machine (ventilator)?
  4. Are you receiving or about to start liquid food through a tube?
  5. Do you not have certain pre-existing conditions like severe diabetes or dementia?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly chosen to either receive your liquid food continuously (meaning over 24 hours, day and night, as is standard care) or to receive it only during the daytime (between 8 am and 10 pm). Both groups will get the same total amount of food; it's just the timing that's different for some people. You will still receive all your regular care on the intensive care unit.

Once you are well enough to understand and discuss the study fully, you will be asked if you are happy to continue taking part and give your formal consent. After about 90 days (about three months) from joining the study, we would ask you to complete two short questionnaires. This is to help the researchers understand how you are doing after your intensive care stay. The study is expected to run from November 2025 until March 2027.

Potential risks and benefits

There is currently no evidence that receiving your tube feed only during the daytime causes any harm or extra risks compared to continuous feeding. We can't promise that you will personally feel better or directly benefit from taking part in this study. However, by helping us learn if daytime-only feeding can reduce confusion in intensive care, you could help future patients. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospitals Plymouth NHS Trust
    City only
    Plymouth, England
  • University Hospital Southampton NHS Foundation Trust
    City only
    Southampton, England

Common questions

What is 'delirium'?

Delirium is a state of confusion that can happen when someone is very sick. It can make you feel disoriented, struggle to concentrate, or see things that aren't there.

Will I get less food if I'm in the daytime-only feeding group?

No, you will receive the same total amount of food your body needs. It will just be given over a shorter period of time, between 8 am and 10 pm.

Will I still get my normal medical care?

Yes, all study participants will continue to receive the full standard care from the intensive care team, exactly as they would if they weren't in the study.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and your medical care will not be affected.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Tim Macdonald

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

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