AuthorisedTherapeutic confirmatory (Phase III)Interventional

Double blind, multicenter, randomized, controlled trial of dexmedetomidine vs placebo in premature neonates receiving invasive ventilation

This important study is testing a new medicine called dexmedetomidine for very premature babies. These babies often need machines to help them breathe, which can be uncomfortable or painful. Doctors usually give them strong pain relief medicines (opioids) like morphine. This study wants to find out if giving dexmedetomidine can help reduce how much of these strong pain medicines babies need, while still making sure they are calm and comfortable. Researchers will compare babies who receive dexmedetomidine with those who receive a placebo (a dummy medicine) to see if it works better and is safe. The goal is to improve how we care for these vulnerable newborns.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrolment target

246

Start

18 Feb 2026

Neonatal respiratory distress. Pain and discomfort

What is this study about?

This study is designed to help us understand if a medicine called dexmedetomidine can make a difference for premature babies. When babies are born very early, their lungs aren't fully developed, and they often need machines to help them breathe, known as invasive ventilation. This process can be uncomfortable or even painful for the baby, so doctors often give them strong pain relief medication, like morphine, that belongs to a group of medicines called opioids.

The main goal of this study is to see if dexmedetomidine can reduce the total amount of these strong opioid pain medicines (like morphine, sufentanil, or fentanyl) that a baby needs. This is important because while opioids are good at relieving pain, they can also have side effects. Researchers will carefully measure how much pain relief each baby receives over a specific period.

They'll also be looking at many other things to make sure the babies are safe and comfortable. This includes checking their pain levels, how many days they need pain medication, and any possible side effects from both the opioids and the new medicine (dexmedetomidine). Over the longer term, the study will also follow the babies to see how their development progresses, checking important milestones at ages two and six.

Key takeaways

The study tests a new medicine (dexmedetomidine) for premature babies.
It aims to reduce the strong pain relief (opioids) babies need.
Babies will receive either the study drug or a dummy medicine (placebo).
Close monitoring for comfort, safety, and development will occur.
Long-term follow-up will check development until age 6.

Who may be eligible?

This study is open to both baby boys and girls. Because it involves very small, premature babies who need breathing support, the study will typically include newborns who are in intensive care.

There might be other specific health conditions or treatments that mean a baby can or cannot join the study. These decisions are made by the doctors involved in the study to ensure the baby's safety and that the study results are clear.

If you have a premature baby who is receiving breathing support, the medical team will be able to tell you if your baby meets the necessary criteria to be considered for 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.

Is my baby very premature?
Does my baby need a machine to help them breathe (ventilation)?
Is my baby able to be looked after in a specialist unit (NICU)?
Does my baby meet the specific health requirements for the study?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive either the study medicine, dexmedetomidine, or a placebo (a dummy medicine that looks the same but contains no active drug). Neither you nor your baby’s doctors will know which treatment your baby is receiving. This is to ensure the study is fair and unbiased.

Throughout the study, nurses and doctors will carefully monitor your baby's comfort levels, pain, breathing, and general well-being. They will also keep track of any other medicines your baby receives, especially pain relief. There will be regular checks to measure specific health markers. After your baby leaves the hospital, there will be follow-up appointments at age 2 and again at age 6 to check on their development. The total duration of active treatment will depend on how long your baby needs breathing support, but the follow-up will last until your child is 6 years old.

Potential risks and benefits

Taking part in this study could potentially benefit your baby by helping to reduce the amount of strong pain relief they need, which could lessen some side effects. However, there's no guarantee of direct benefit for your baby. As with any medicine, there are potential risks and side effects associated with dexmedetomidine, such as changes in heart rate or blood pressure, which will be closely monitored. There are also risks associated with receiving a placebo instead of active treatment if dexmedetomidine proves to be beneficial. Your baby's safety is the highest priority, and medical staff will be continuously monitoring for any concerns. You have the right to withdraw your baby from the study at any time, for any reason, 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.

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Unverified
France

Common questions

What is dexmedetomidine?

It's a medicine being tested in this study that might help keep premature babies calm and comfortable, potentially reducing the need for strong pain relief.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the study drug but doesn't contain any active ingredients. It's used to fairly compare the real medicine's effects.

Will I know if my baby is getting the study drug or the placebo?

No, neither you nor your baby's doctors will know which treatment your baby is receiving. This helps make the study results as accurate as possible.

What kind of follow-up will my baby need?

After leaving the hospital, there will be checks at age 2 and age 6 to see how your child is developing.

Can I take my baby out of the study?

Yes, you can decide to withdraw your baby from the study at any time without it affecting the care they receive.