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Not yet recruiting NCT07493785

Dexmedetomidine for Invasive Ventilation In the NEOnate

Phase II / Phase III Interventional Invasive Ventilation Infant Pain Infant Discomfort Infant Neurodevelopment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution.
Who it may be relevant to
Registry conditions: Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment. Basic parameters: up to 10 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Dexmedetomidine Injectable Solution
    Intravenous administration for maximum 20 days
  • Drug Glucose 5% Injectable Solution
    Intravenous administration for maximum 20 days

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • Duration of invasive ventilation in hours [Time frame: 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]
  • 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]
  • 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]
  • 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]
  • Rate of extubation failure [Time frame: 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]
  • Age at full enteral feeding in postmenstrual age (weeks) [Time frame: 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

France · 12 centers
  • CHU Brest - Hôpital Morvan — Brest
  • Centre Hospitalier Intercommunal de Créteil — Créteil
  • CHU Grenoble Alpes — Grenoble
  • CHRU Lille — Lille
  • CHU Limoges — Limoges
  • CHU de Nantes — Nantes
  • CHU de Nice — Nice
  • AP-HP Hôpital Necker Enfants Malades — Paris
  • … and 4 more centers

Identifiers

NCT: NCT07493785 · DIVINEO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗