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Study on Sedation Effects of Dexmedetomidine vs. Midazolam in Mechanically Ventilated Preterm Infants

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What is this trial about?

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

This clinical trial is focused on studying the effects of two different sedative medications, dexmedetomidine and midazolam, on very preterm infants who require mechanical ventilation. Very preterm infants are babies born before 32 weeks of pregnancy and may need help with breathing through a machine. The purpose of the study is to compare how these medications affect the time it takes for these infants to be safely removed from the ventilator, a process known as extubation.

During the study, infants will receive either dexmedetomidine or midazolam as part of their sedation while on mechanical ventilation. The study will observe how long it takes for the infants to be extubated after stopping the sedative medication. Additionally, researchers will monitor other factors such as the need for additional pain relief, the time it takes for the infants to reach a comfortable state, and any potential side effects related to heart rate, blood pressure, or breathing.

The study aims to provide valuable information on which sedative might be more effective and safer for very preterm infants in this critical care setting. The trial is expected to run until December 2028, with recruitment starting in September 2024. This research could help improve care for very preterm infants who need mechanical ventilation by identifying the best sedation practices.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves very preterm infants who are admitted to the neonatal intensive care unit (NICU) and require sedation for mechanical ventilation.
Eligibility criteria include a gestational age at birth of less than 32 weeks and a corrected gestational age of less than 45 weeks.
Infants must not have had a previous extubation within 7 days, must not be receiving Clonidine treatment, and must not have hemodynamic instability or be under palliative care.
Step 2
Randomization
Infants are randomly assigned to receive either dexmedetomidine or midazolam for sedation.
Randomization ensures that there is no bias in assigning the treatment groups.
Step 3
Sedation administration
The assigned sedative, either dexmedetomidine or midazolam, is administered intravenously.
Dexmedetomidine is provided as a solution for infusion, while midazolam is given as a solution for injection.
Step 4
Monitoring and assessment
The primary goal is to measure the time to extubation after stopping the sedative.
Secondary assessments include monitoring for any adverse events such as bradycardia or desaturation, and evaluating the need for additional opioid administration.
The Comfort B score, which ranges from 11 to 17, is used to assess the infant's comfort level during sedation.
Step 5
Extubation and follow-up
After sedation is discontinued, the time taken for extubation is recorded.
Follow-up includes checking the intubation rate 24 hours after extubation and monitoring for any severe neonatal morbidity or in-hospital mortality.

Who can join the trial?

12 criteria

The patient must be admitted to the NICU, which is a special area in the hospital for newborns who need intensive medical care.
The patient should not be using a curare agent, which is a type of medication that relaxes muscles.
The patient should not have been extubated, meaning the removal of a breathing tube, within the last 7 days.
The patient should not be receiving Clonidine treatment, which is a medication used for various conditions, including high blood pressure.
The patient should not have hemodynamic instability, which means their blood flow and blood pressure are not stable.
The patient should not be receiving palliative care, which is care focused on providing relief from symptoms and stress of a serious illness.
The patient must have been born at less than 32 weeks of gestation, which is the time a baby spends developing in the womb.
The patient's corrected gestational age should be less than 45 weeks postmenstrual age, which is the age of the baby calculated from the mother's last menstrual period.
The patient must need sedation for invasive mechanical ventilation, which is a machine that helps with breathing.
The sedation should be elective, meaning there is an acceptable delay between deciding to sedate and giving the sedative medication.
The patient must have or be planned to have venous access, which is a way to give medications directly into the bloodstream.
There should be no medical reasons preventing the use of dexmedetomidine or midazolam, which are medications used for sedation.

Who cannot join the trial?

1 criterion

Babies born very early, before 32 weeks of pregnancy, who are not yet 45 weeks old when adjusted for their early birth, and need sedation for breathing support.

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Verified sites

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

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CHU Croix Rousse-Lyon
Lyon, France
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Centre Hospitalier De Pau
Pau, France
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Centre Hospitalier Intercommunal De Poissy Saint Germain
St Germain En Laye, France

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Investigated drugs

Dexmedetomidine
is a medication used for sedation. In this trial, it is being tested to see how well it helps with sedation in very preterm infants who are on mechanical ventilation. The goal is to determine if it can effectively reduce the time it takes for these infants to be safely extubated, meaning the removal of the breathing tube.
Midazolam
is another medication used for sedation. It is being compared to dexmedetomidine in this trial to see which one is more effective in helping very preterm infants who are mechanically ventilated. The focus is on how quickly and safely the infants can be extubated when sedated with midazolam.

Midazolam

What is already known about the treatment

Dexmedetomidine
This medication is administered intravenously and is used primarily for sedation. It is currently being studied in clinical trials for its effectiveness in sedating very preterm neonates who require mechanical ventilation. The main therapeutic indication is sedation in the context of invasive mechanical ventilation for these infants. At the molecular level, dexmedetomidine works by activating alpha-2 adrenergic receptors, which helps to reduce the release of norepinephrine, leading to sedation. It is classified pharmacologically as an alpha-2 adrenergic agonist.
Midazolam
This medication is also administered intravenously and is commonly used for sedation. It is being compared to dexmedetomidine in clinical trials to assess its efficacy in sedating very preterm neonates on mechanical ventilation. The primary therapeutic use is for sedation in these infants. Midazolam acts by enhancing the effect of the neurotransmitter GABA at the GABA-A receptor, which results in sedative effects. It is classified as a benzodiazepine.

Investigated diseases

Very Preterm Neonate – This condition refers to infants born before 32 weeks of gestation. These neonates often require specialized medical care due to their underdeveloped organs and systems. They may need assistance with breathing, feeding, and maintaining body temperature. Invasive mechanical ventilation is commonly used to support their respiratory function. Sedation may be necessary to ensure comfort and stability during such interventions. The condition is characterized by the need for careful monitoring and management to support the infant's development and health.