RecruitingPhase IVInterventional

Dexmedetomidine Trial of Adjunct Treatment with Morphine

This study is investigating a new medicine called dexmedetomidine (or dexmed) to help manage pain in premature babies who need breathing support. Babies born very early often need a ventilator, and while morphine helps with pain, it can have downsides for these tiny infants. Dexmed is used in older children and adults and might offer better pain relief with fewer side effects, potentially helping babies come off the ventilator sooner and improving their development. The study will compare morphine alone with morphine plus one of two doses of dexmed. Researchers will check pain levels, how the body handles the medicines, how quickly babies come off the ventilator, and their development at age two. Parents will receive full information and need to agree for their baby to take part. The study is running in UK hospitals.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Enrolment target

240

Start

30 Mar 2026

Estimated completion

30 Jun 2027

Pain in ventilated babies

What is this study about?

This study is about finding better ways to manage pain in premature babies who need help breathing with a machine called a ventilator. Babies born very early (before 32 weeks of pregnancy) often need this support. To keep them comfortable, doctors usually give them pain relief like morphine. However, morphine can sometimes cause problems for these tiny babies, such as affecting their brain development or making it harder for them to come off the ventilator.

We are looking into a different medicine called dexmedetomidine, or 'dexmed' for short. This medicine is already used safely in older children and adults to help with pain and sedation. We think it might be a good option for premature babies, potentially offering powerful pain relief with fewer of the side effects sometimes seen with morphine.

Our main goal is to see if giving dexmed alongside morphine can help us use less morphine overall. We also want to find out if this combination helps babies recover better, come off the ventilator sooner, and supports their healthy development as they grow. Ultimately, we hope to improve the care and long-term health outcomes for these vulnerable babies.

Key takeaways

Exploring a new pain relief option for very premature babies on ventilators.
Aims to reduce morphine use and improve long-term development.
Babies will be closely monitored in intensive care.
Parents provide consent and complete follow-up questionnaires from home.
Funded by a major UK health research body, NIHR.

Who may be eligible?

This study is for very premature babies born before 32 weeks of pregnancy who are already six days old or older. They must need a ventilator to help them breathe and are expected to need it for at least two more days. Importantly, they must also be receiving or about to receive morphine for pain relief.

There are some reasons why a baby might not be able to join the study. This includes if their mum received certain strong pain medications during pregnancy (not counting during labour). Also, if a baby has a major birth defect, is very unwell with unstable blood pressure despite strong medicines, or is likely to be moved to another hospital very soon, they wouldn't be able to take part. Finally, if doctors believe there's no realistic chance of survival, the baby wouldn't be included.

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.

Is my baby born before 32 weeks of pregnancy?
Is my baby currently on a ventilator and likely to need it for at least two more days?
Is my baby already receiving or about to receive morphine for pain?
Are there no major birth defects or very unstable health issues?
Has my baby's mother not received opiates during pregnancy (other than during labour)?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, they will randomly receive one of three treatments: morphine alone, or morphine with one of two different doses of dexmed. To ensure the study is fair and unbiased, some babies receiving only morphine will also get a 'dummy' medicine (placebo) that looks identical to dexmed, so no one involved in their care knows which treatment they are on.

Throughout the study, nurses and doctors will regularly check your baby's pain levels and comfort, just like they do for all babies in intensive care. Medicines will be adjusted as needed to keep them comfortable. We will take small blood samples, but only at times when your baby would already be having blood tests as part of their routine care, so there are no extra pokes. Researchers will track how quickly babies come off the ventilator and follow their development up to 2 years of age. You will be asked to complete questionnaires about your baby's development, which you can do from home by post, online, or over the phone. Parents do not need to attend any extra hospital visits, and the study will run until about April 2030.

Potential risks and benefits

Participating in this study might offer some potential benefits. Dexmed could help reduce the amount of morphine your baby needs, which might lead to better brain development and an easier time coming off the ventilator. However, like all medicines, dexmed has potential risks; it can temporarily lower heart rate and blood pressure, though we are using doses that have been safely tested in other children. All babies in the study will be very closely watched in the intensive care unit, and doctors can adjust or stop any medicines if there are concerns. Blood samples will be taken during routine care to avoid extra discomfort for your baby, and you have the right to withdraw your baby from the study at any time without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Not provided at time of registration
City only
-, England

Common questions

What is dexmedetomidine?

It's a medicine used to help with pain and relaxation, already given to older children and adults. We're studying if it can help premature babies.

Will my baby get less pain relief?

No, your baby's comfort is the top priority. Doctors will regularly check pain levels and adjust medicines to ensure they are comfortable, regardless of the treatment group.

How long will my baby be in the study?

Your baby will receive their assigned treatment while on the ventilator. Follow-up for their development will continue until they are about 2 years old.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), a large UK government funder of health research.

What if I change my mind about my baby participating?

You can withdraw your baby from the study at any time, for any reason. Their medical care will not be affected in any way.

How to find out more

Shalini Ojha

shalini.ojha@nottingham.ac.uk +44 (0)7469 037398 Official trial record

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