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New drug may help preemies breathe easier, avoid opioids

NCT ID NCT07493785

Symptom relief Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study tests dexmedetomidine, a sedative that doesn't slow breathing, in 246 premature babies on ventilators. The goal is to see if it reduces the need for opioids, shortens time on the breathing machine, and improves long-term brain development. Babies will receive the drug or a placebo for up to 20 days.

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 offer a safer way to sedate ventilated premature babies, reducing opioid use and potentially protecting their brain development.
What could go wrong
This is an early-to-mid stage trial with 246 babies. The drug may not reduce opioid use or improve outcomes, and side effects like low blood pressure or slow 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 246 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Feb 2034

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 10 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.

Above mentioned age limits (0 -10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks). Inclusion Criteria: * Neonates with a gestational age at birth \< 32 weeks of gestation and corrected gestational age \< 32 weeks postmenstrual age * Invasively ventilated with an expected or effective duration of ventilation \> 24 hours at inclusion * Under mechanical ventilation since less than 72 hours at inclusion * With parental consent * Affiliated to or benefiting from a social security system Exclusion Criteria: * Previous inclusion in this trial * Participation in another trial including analgesics or sedatives * Ongoing palliative care * Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours * Hemodynamic compromise defined as any of: poor perfusion (increased capillary refill time, oliguria); hypotension defined as a mean blood pressure in mm Hg \< postmenstrual age in weeks; ongoing inotropic treatment with dopamine or dobutamine ≥ 5 µg/kg/min, or any other inotropic drug at any dose, or need for more than one volume expansion (20 ml/kg) in the 6 previous hours * Pulmonary hypertension requiring pharmacological treatment * Heart rate \<100 bpm * Hepatic impairment defined as alanine aminotransferase level \> 2 x normal upper limit * Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event * Hypersensitivity to the active substance or to any of the excipients contained in the medicine

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Conditions

The condition(s) this trial relates to.

agnosia neonatal respiratory failure neurodevelopmental disorder Pain substance withdrawal syndrome

As listed by the trial registrant

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

Infant discomfort Infant neurodevelopment Infant pain Invasive ventilation Neonatal respiratory failure

How to take part

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

  1. The places running it

    12 sites. 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

  • AP-HP Hôpital Necker Enfants Malades

    Paris, 75015, France

  • CHRU Lille

    Lille, 59000, France

  • CHU Brest - Hôpital Morvan

    Brest, 29609, France

  • CHU Félix Guyon (Saint Denis)

    Saint-Denis, 97400, France

  • CHU Grenoble Alpes

    Grenoble, 38700, France

  • CHU Limoges

    Limoges, 87042, France

  • CHU de La Réunion - Site Sud Saint-Pierre

    Saint-Pierre, 97400, France

  • CHU de Nantes

    Nantes, 44000, France

  • CHU de Nice

    Nice, 6200, France

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000, France

  • Centre Hospitalier de Saint -Denis

    Saint-Denis, 93200, France

  • Hôpital NOVO - Site de Pontoise

    Pontoise, 95300, France

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