RecruitingPHASE3INTERVENTIONAL

Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants

This research is looking at very premature babies (born before 32 weeks) who need help breathing with a machine. These babies often need medicine to keep them calm and comfortable. We’re comparing two different sedatives: dexmedetomidine and midazolam. Doctors typically use midazolam, but there are some concerns about its side effects and how long it might keep babies on the breathing machine. Dexmedetomidine is a newer option that might help babies come off the breathing machine sooner while still keeping them comfortable. The aim is to find out if dexmedetomidine helps these fragile babies recover faster and reduces the risk of lung problems.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

380

Start

16 Oct 2025

Estimated completion

16 Oct 2029

PreTerm Neonate Sedation for Invasive Mechanical Ventilation Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation

What is this study about?

When tiny babies are born very early (before 32 weeks), their lungs might not be fully developed, so they often need help breathing using a special machine. To make this easier and more comfortable for them, doctors give them medicine to relax and sleep, which we call sedation. This study is like a careful comparison test between two different medicines used for sedation: midazolam, which has been used for a while, and dexmedetomidine, a newer option.

We know that staying on a breathing machine for a long time can sometimes cause problems for a baby's developing lungs. One of the main goals for these babies is to get them off the breathing machine as safely and quickly as possible. While midazolam helps with comfort, there are some worries that it might slow down the process of weaning babies off the machine or have other effects. Dexmedetomidine might work differently, potentially allowing babies to breathe more on their own and come off the machine sooner, which could be better for their long-term health.

So, the main reason for this study is to see if dexmedetomidine can help very premature babies finish their time on a breathing machine more quickly compared to midazolam, while still keeping them calm and without causing new problems. By carefully looking at how well the medicines work, how quickly babies come off the machine, and any side effects, the research team hopes to find the best and safest way to care for these vulnerable infants.

Key takeaways

This study compares two sedatives for very premature babies (born before 32 weeks).
It aims to see if dexmedetomidine helps babies come off breathing machines sooner than midazolam.
Babies taking part will be randomly given either dexmedetomidine or midazolam.
Doctors will carefully monitor your baby's progress and vital signs.
The findings could improve future care for premature babies needing breathing support.

Who may be eligible?

This study is for very premature babies. This means babies born before 32 weeks of pregnancy. They need to be in a special care unit (NICU) and require a breathing machine, or are expected to need one soon, and also require sedation.

Before a baby can join, doctors will check if they need sedation for the breathing machine. They must also have a vein accessible for medicine, and no serious health issues that would make taking these medicines unsafe. They cannot have been given dexmedetomidine or midazolam within the last two days, except for the initial procedure to put them on the breathing machine.

Babies would not be able to join if they have unstable blood pressure, are receiving comfort care only, or have certain other medical conditions. They also can’t be taking other specific medications that might interfere with the study medicines.

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?
Does my baby need a breathing machine, or is it likely they will soon?
Does my baby need medicine to stay calm while on the breathing machine?
Does my baby have stable blood pressure and no other serious health issues that doctors are aware of?
Has my baby not received sedatives like midazolam or dexmedetomidine in the last 48 hours (except for the initial intubation)?
Are we able to provide written agreement for our baby to take part?

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 be randomly assigned to receive either dexmedetomidine or midazolam. This is like flipping a coin, so neither you nor the doctors choose which medicine your baby gets. Both medicines will be given continuously into a vein.

The medical team will carefully watch your baby's vital signs, like heart rate and breathing, very closely. These checks will happen frequently at the beginning (every few minutes to an hour) and then every few hours. The amount of medicine will be adjusted by the doctors to make sure your baby is comfortable. The study will continue until your baby no longer needs the breathing machine and sedation, which varies for each baby.

Potential risks and benefits

Participating in this study means your baby will receive one of two sedatives, both of which are regularly used in hospitals. Midazolam has known benefits for comfort but also potential side effects like low blood pressure. Dexmedetomidine is hoped to help babies come off breathing machines sooner, but like all medicines, it has potential side effects which the doctors will monitor closely. The information gathered may help improve care for other premature babies in the future. You have the right to withdraw your baby from the study at any time, for any reason, without affecting their care.

Locations (1)

Hospital Armand Trousseau, APHP Service : Department of Neonatology
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'very premature baby'?

A very premature baby is one born before 32 weeks of pregnancy, much earlier than the due date.

Why do premature babies need sedatives?

Sedatives help keep premature babies calm and comfortable, especially when they need a breathing machine, which can be upsetting for them.

What is 'randomly assigned'?

This means your baby will be put into one of two groups by chance, like drawing names from a hat. This makes the study fair and scientific.

What is the main goal of this study?

The main goal is to see if one sedative (dexmedetomidine) can help very premature babies come off their breathing machines faster than the other (midazolam).

Will my baby still get the best possible care?

Yes, your baby will receive the highest standard of care throughout the study, with their comfort and safety being the top priority.

How to find out more

Clément CHOLLAT, MD, PhD, Associate Professor

clement.chollat@aphp.fr +33 6 86 72 29 58 Official trial record

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