Dexmedetomidine for Invasive Ventilation In the NEOnate

NCT07493785 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DIVINEO
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Invasive Ventilation; Neonatal Respiratory Failure; Infant Pain; Infant Discomfort; Infant Neurodevelopment

Keywords

Neonatology; Invasive mechanical ventilation; Analgesia; Dexmedetomidine; Neurodevelopment; Opioids; Pain; Withdrawal syndrome

Outcome Measures

Primary Outcomes (1)

• Dose of Opioids used

  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 Outcomes (30)

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

  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

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

• Number of days with opioids and/or benzodiazepines

  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

  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

  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

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine Injectable Solution

Glucose 5%

PLACEBO COMPARATOR

Drug: Glucose 5% Injectable Solution

Interventions

Glucose 5% Injectable Solution DRUG

Intravenous administration for maximum 20 days

Glucose 5%

Dexmedetomidine Injectable Solution DRUG

Intravenous administration for maximum 20 days

Dexmedetomidine

Eligibility Criteria

• Age: Up to 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with a gestational age at birth \< 32 weeks of gestation and corrected gestational age \< 32 weeks postmenstrual age
• With parental consent
• Affiliated to or benefiting from a social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Pr Xavier DURRMEYER: collaborator

Study Sites (12)

CHU Brest - Hôpital Morvan

Brest, 29609, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

CHU Grenoble Alpes

Grenoble, 38700, France

Location

CHRU Lille

Lille, 59000, France

Location

CHU Limoges

Limoges, 87042, France

Location

CHU de Nantes

Nantes, 44000, France

Location

CHU de Nice

Nice, 6200, France

Location

AP-HP Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Hôpital NOVO - Site de Pontoise

Pontoise, 95300, France

Location

Centre Hospitalier de Saint -Denis

Saint-Denis, 93200, France

Location

CHU Félix Guyon (Saint Denis)

Saint-Denis, 97400, France

Location

CHU de La Réunion - Site Sud Saint-Pierre

Saint-Pierre, 97400, France

Location

MeSH Terms

Conditions

Agnosia; Pain; Substance Withdrawal Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Xavier DURRMEYER, MD, PhD

CONTACT

0157023468; Durrmeyer.Xavier@chicreteil.fr

Manon TAUZIN, MD

CONTACT

0157022000; Manon.Tauzin@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Use of similar vials and labels for the 2 allocation arms. Masking of the result of randomization (arm description) in the eCRF. Only the treatment unit number will appear on the eCRF for administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, multicenter, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): August 1, 2034
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

FR (12)