Dexmedetomidine for Invasive Ventilation In the NEOnate

March 20, 2026 updated by: Centre Hospitalier Intercommunal Creteil

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

246

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
Drug: Dexmedetomidine Injectable Solution
Intravenous administration for maximum 20 days
Placebo Comparator: Glucose 5%
Drug: Glucose 5% Injectable Solution
Intravenous administration for maximum 20 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Duration of invasive ventilation in hours
Time Frame: From inclusion to first planned extubation or unplanned extubation lasting at least 24 hours
From inclusion to first planned extubation or unplanned extubation lasting at least 24 hours
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
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 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
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 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
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
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
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
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
Within 7 days after the first planned extubation
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
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
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
From inclusion to hospital discharge, assessed up to 24 weeks
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
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
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
Within 7 days of the first planned extubation or unplanned extubation lasting at least 24 hours
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
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 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.
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
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.
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 In-hospital deaths
Time Frame: At 36 weeks postmenstrual age
At 36 weeks postmenstrual age
Number of In-hospital deaths
Time Frame: From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks
From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting bronchopulmonary dysplasia
Time Frame: At 36 weeks postmenstrual age
To respond secondary objective of severe neonatal morbidities
At 36 weeks postmenstrual age
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
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
At 2 years corrected age +/- 2 months
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
At age 6 years +/- 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Pr Xavier DURRMEYER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2032

Study Completion (Estimated)

August 1, 2034

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIVINEO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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