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Dexmedetomidine for Invasive Ventilation In the NEOnate

NCT07493785 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-08-26

No results posted yet for this study

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
  • Infant Pain
  • Infant Discomfort
  • Infant Neurodevelopment
  • Neonatal Respiratory Failure

Interventions

DRUG

Dexmedetomidine Injectable Solution

Intravenous administration for maximum 20 days

DRUG

Glucose 5% Injectable Solution

Intravenous administration for maximum 20 days

Sponsors & Collaborators

  • Pr Xavier DURRMEYER

    collaborator UNKNOWN

  • Centre Hospitalier Intercommunal Creteil

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2033-01-01
Completion
2034-02-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493785 on ClinicalTrials.gov