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NCT Number: NCT07493785

Dexmedetomidine for Invasive Ventilation In the NEOnate

Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain.

As opposed to the adult and pediatric population, routine use of opioids or midazolam is not recommended in ventilated neonates.

Although opioids are the most frequently prescribed analgosedative drugs in ventilated premature neonates, their use is controversial because of the risk of respiratory depression - which can prolong invasive ventilation- and concerns on long-term neurodevelopment.

Dexmedetomidine, a selective alpha-2- adrenergic agonist routinely used in the adult ICU (intensive care unit), provides light sedation and some analgesia with no or little respiratory-depression effect. It also has neuroprotective properties after pediatric cardiac surgery and in neonatal animal models. Dexmedetomidine is thus a promising candidate drug in ventilated premature neonates that might reduce the duration of mechanical ventilation and preserve neurodevelopment in this vulnerable population.

The investigators hypothesize that the use of dexmedetomidine in ventilated premature neonates could decrease the need for opioids, facilitate extubation and thereby preserve long-term neurodevelopmental outcome.

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Key information

Conditions

Invasive Ventilation Agnosia Chemically-Induced Disorders Infant Discomfort Infant Neurodevelopment Infant Pain Mental Disorders Neonatal Respiratory Failure Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Substance Withdrawal Syndrome Substance-Related Disorders

Age range

Up to 10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Brest - Hôpital Morvan, Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Injectable Solution

Drug

Intravenous administration for maximum 20 days

Glucose 5% Injectable Solution

Drug

Intravenous administration for maximum 20 days

Primary outcomes

  1. Dose of Opioids used

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last.

Secondary outcomes

  1. Percentage of time (hours) spent within an excessive/appropriate/ insufficient comfort/analgesia state based on the COMFORTneo scale

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    Scores of COMFORTneo scale :

    • excessive: score <11
    • appropriate: score between 11 to 13
    • insufficient : score >13

  2. Duration of invasive ventilation in hours

    Time frame: From inclusion to first planned extubation or unplanned extubation lasting at least 24 hours

  3. Number of days with opioids and/or benzodiazepines

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

  4. Cumulative dose of midazolam or other benzodiazepines

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

  5. Number of days with paracetamol use

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

  6. Frequency of muscle blocker use to improve ventilation

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    Number of patients receiving muscle bocker

  7. Rate of extubation failure

    Time frame: Within 7 days after the first planned extubation

    Number of reintubation within 7 days after the first planned extubation

  8. Rate of unplanned extubation

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

  9. Age at full enteral feeding in postmenstrual age (weeks)

    Time frame: From inclusion to hospital discharge, assessed up to 24 weeks

    To respond to the secondary objective : frequency of opioid-related adverse effects

  10. Frequency of urinary retention episodes

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    To respond to the secondary objective : frequency of opioid-related adverse effects

  11. Finnegan neonatal withdrawal scale or any other validated withdrawal scale

    Time frame: Within 7 days of the first planned extubation or unplanned extubation lasting at least 24 hours

    To respond to the secondary objective : frequency of opioid-related adverse effects

  12. Number of Bradycardia episodes

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    Heart rate < 100/min for 5 consecutive minutes

  13. Number of hypotension episodes

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    Mean arterial blood pressure in mmHg < postmenstrual age in weeks.

  14. Frequency of anti-hypotensive treatments use

    Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last

    Volume expansion (at least 10 ml/kg), dopamine, dobutamine, epinephrine, norepinephrine, milrinone or hydrocortisone for hemodynamic support.

  15. Number of In-hospital deaths

    Time frame: At 36 weeks postmenstrual age

  16. Number of In-hospital deaths

    Time frame: From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks

  17. Total duration of invasive ventilation

    Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    Number of days

  18. Total duration of non-invasive ventilation

    Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    Number of days

  19. Total duration of NICU stays

    Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    Number of days

  20. Total duration Hospital stay

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    Number of days

  21. Number of patients presenting high-grade intraventricular hemorrhage Grade 3 and 4

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of neonatal morbidities

  22. Number of patients presenting periventricular leukomalacia

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of severe neonatal morbidities

  23. Number of patients presenting secondary sepsis

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of severe neonatal morbidities

  24. Number of patientsTreated for patent ductus arteriosus

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of severe neonatal morbidities

  25. Number of patients presenting bronchopulmonary dysplasia

    Time frame: At 36 weeks postmenstrual age

    To respond secondary objective of severe neonatal morbidities

  26. Number of patients presenting necrotizing enterocolitis

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of severe neonatal morbidities

  27. Number of patients presenting isolated intestinal perforation

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of severe neonatal morbidities

  28. Number of patients presenting treated retinopathy of prematurity

    Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks

    To respond secondary objective of severe neonatal morbidities

  29. Long-term neurodevelopment using tests validated in French : Parent Report of Children's Abilities-Revised (PARCA-R)

    Time frame: At 2 years corrected age +/- 2 months

    Higher scores indicate improved neurodevelopment

  30. Long-term neurodevelopment using tests validated in French : BMT-i (Batterie Modulable de Tests informatisée, or "computerized Adaptable Test Battery")

    Time frame: At age 6 years +/- 2 months

    Higher scores indicate improved neurodevelopment

Study contacts

Contact information is provided by the study sponsor or research team.

Manon TAUZIN, MD

CONTACT

[email protected]

0157022000 ext. 8407

Xavier DURRMEYER, MD, PhD

CONTACT

[email protected]

0157023468

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • Pr Xavier DURRMEYER

Registry information

Official study title

Double Blind, Multicenter, Randomized, Controlled Trial of Dexmedetomidine vs Placebo in Premature Neonates Receiving Invasive Ventilation

Important dates

Study start
2026
Primary completion
2032
Study completion
2034
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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