New drug may help preemies breathe easier, avoid opioids

NCT ID NCT07493785

Not yet recruiting Symptom relief Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 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.

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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

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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