Study of dexmedetomidine versus placebo to reduce opioid use in premature babies requiring mechanical ventilation for respiratory distress

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What is this study about?

This study focuses on premature infants who are experiencing neonatal respiratory distress, a condition where a newborn has difficulty breathing, and who require invasive ventilation, which is a method of using a machine to help a baby breathe through a tube. The purpose of the study is to evaluate whether the use of dexmedetomidine can reduce the total amount of opioids, such as morphine, sufentanil, or fentanyl, needed to manage pain and discomfort in these infants. Opioids are strong medications used to relieve pain.

During the study, infants will receive either dexmedetomidine or a placebo through an intravenous infusion, which means the medication is delivered directly into a vein. Participants will be assigned to one of these two groups by chance. The process involves monitoring the infants while they are receiving breathing support to see how the different treatments affect their need for pain medication and their overall comfort levels.

Who Can Join the Study?

  • The baby must have been born before 32 weeks of pregnancy (this is known as gestational age, which refers to how far along the pregnancy was).
  • The baby’s corrected gestational age, which is the age the baby would be if they had been born on their original due date, must be less than 32 weeks.
  • The baby must be receiving invasive mechanical ventilation, which means a machine is being used to help them breathe through a tube placed in their airway.
  • The time the baby is expected or actually needs to stay on the breathing machine must be longer than 24 hours.
  • The baby must have been on the breathing machine for less than 72 hours at the time they join the study.
  • The parents or legal guardians must provide consent, which means they must officially agree to let the baby participate.
  • The family must be part of or receive benefits from a social security system, which is a government program that helps pay for medical costs.

Who Cannot Join the Study?

  • Having already participated in this specific study before.
  • Having an allergy (a bad reaction) to the main medicine being studied or to any of the other ingredients used to make the medicine.
  • Being part of a different medical study that involves analgesics (painkillers) or sedatives (medicines that make you sleepy or calm).
  • Currently receiving palliative care (medical care focused on providing comfort rather than curing an illness).
  • Having received dexmedetomidine or another alpha-2 agonist (a type of medicine that affects the nervous system) within the last 96 hours.
  • Having hemodynamic compromise, which means the body is struggling to maintain stable blood flow and pressure. This includes:
    • Poor perfusion, which is when blood does not reach the body’s tissues well enough (shown by slow skin color return after pressing on it or producing very little urine).
    • Hypotension, which is low blood pressure.
    • The need for inotropic treatment, which refers to medicines like dopamine or dobutamine used to help the heart pump stronger.
    • The need for large amounts of fluids to increase blood volume in a short time.
  • Having pulmonary hypertension, which is high blood pressure in the arteries of the lungs, that requires medication to treat.
  • Having a heart rate (the number of times the heart beats per minute) that is lower than 100 beats per minute.
  • Having hepatic impairment, which means the liver is not working properly, specifically marked by high levels of a certain liver enzyme called alanine aminotransferase.
  • Having known reasons why dexmedetomidine should not be used, such as:
    • Atrioventricular block (a problem with the electrical signals that control the heartbeat).
    • An acute cerebrovascular event (a sudden medical problem in the brain, such as a stroke).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France
Hôpital Archet 2 Nice France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier De Saint-Denis St Denis France
CHU Brest / Hôpital Morvan Brest France
Centre Hospitalier Universitaire de la Réunion – Site Sud Saint Pierre France
APHP Necker Paris France
CHU Limoges / Hôpital de la Mère et de l’Enfant Limoges France
CHU La Réunion Nors St Denis France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.02.2026

Trial locations

Investigated drugs:

Dexmedetomidine is a medication given through a vein as a continuous infusion to help calm and relax premature babies who are receiving breathing support through a machine.

Neonatal respiratory distress – This condition occurs when a newborn baby has difficulty breathing shortly after birth. It is common in premature infants whose lungs are not yet fully developed. The condition often progresses as the baby struggles to maintain adequate oxygen levels. It may require the use of breathing support through machines to assist with respiration.

Trial ID:
2023-509247-27-00
Protocol code:
DIVINEO
Trial Phase:
Therapeutic confirmatory (Phase III)

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