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New sedative could help preterm babies breathe on their own faster

NCT ID NCT06878703

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two sedatives, dexmedetomidine and midazolam, in very premature babies who need a breathing tube. The goal is to see if dexmedetomidine helps them come off the ventilator sooner, which could reduce lung injury. About 380 babies born before 32 weeks will take part across multiple hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexmedetomidine
What this could lead to
If it works, this could lead to a safer sedation option for preterm babies, helping them get off ventilators sooner and reducing lung damage.
What could go wrong
This is a phase 3 trial, but results may not apply to all preterm infants. Dexmedetomidine may not shorten breathing tube time as hoped, and side effects like low heart rate are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 32 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient admitted in NICU (intubated or not yet), * Gestational age at birth \< 32 weeks of gestation (WG), * Corrected gestational age \<45 weeks postmenstrual age Written or electronic informed consent signed by both parents. Randomization Criteria : * Indication for sedation in the context of invasive mechanical ventilation, * Patient intubated or not yet, * Elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent), * Presence or plan of a venous access, * No medical contraindication related to the administration of dexmedetomidine or midazolam, * No previous use of dexmedetomidine or midazolam within 48 hours, except for the sedation procedure for intubation, * No concomitant use of curare agent, * No clonidine treatment, * No previous extubation within 7 days, * No hemodynamic instability * No palliative care, Exclusion Criteria: * Patient admitted in NICU (intubated or not yet), * Gestational age at birth \< 32 weeks of gestation (WG), * Corrected gestational age \<45 weeks postmenstrual age Written or electronic informed consent signed by both parents.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preterm neonate Sedation for invasive mechanical ventilation Very preterm neonates with sedation for invasive mechanical ventilation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Armand Trousseau, APHP Service : Department of Neonatology

    RECRUITING

    Paris, 75012, France

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