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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of study medication
After joining the study, one of two substances will be given through an intravenous infusion, which is a liquid delivered directly into a vein.
The first option is dexmedetomidine, administered at a dose of 24 µg/kg (micrograms per kilogram of body weight).
The second option is a placebo, which is a substance without active medicine, consisting of glucose 5% at a dose of 1.2 g (grams).
Step 2
Monitoring and observation period
During the period when the dexmedetomidine or placebo is being administered, various health indicators will be monitored.
The monitoring includes the total amount of opioids (pain-relief medicines such as morphine, sufentanil, or fentanyl) used.
Levels of pain and comfort will be assessed using a specific scale.
The heart rate (to check for bradycardia, which is a slow heart rate), blood pressure (to check for hypotension, which is low blood pressure), and the use of muscle blockers will be observed.
Other factors such as feeding age, breathing support duration, and potential side effects will be tracked.
Step 3
Follow-up and long-term assessment
Health and safety outcomes will be observed at the time of hospital discharge.
Long-term neurodevelopment, which refers to how the brain and nervous system develop, will be evaluated using specific tests at 2 years of age and 6 years of age.

Who can join the trial?

7 criteria

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 trial?

14 criteria

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.
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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.
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  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).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Centre Hospitalier De Saint-Denis
St Denis, France
Verified
Centre Hospitalier Intercommunal Creteil
Creteil, France

Trial locations

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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.

What is already known about the treatment

Dexmedetomidine
This medication is given as a continuous liquid drip directly into a vein through an intravenous infusion. It is an established medicine used in intensive care to help calm patients and reduce pain during medical procedures. It works by specifically targeting and activating certain receptors in the brain that help control sedation and sleep. This drug is classified as a selective alpha-2 adrenergic agonist.
Glucose
This substance is administered as a liquid solution through a vein via an intravenous infusion. In this clinical trial, it is being used as a placebo, which is an inactive substance used for comparison. It is a simple sugar that serves as a primary energy source for the body's cells. This substance is classified as a carbohydrate.

Investigated diseases

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.