Dexmedetomidine for Invasive Ventilation In the NEOnate

Centre Hospitalier Intercommunal Creteil

Status and phase

Begins enrollment this month

Phase 3

Phase 2

Conditions

Neonatal Respiratory Failure

Infant Discomfort

Invasive Ventilation

Infant Neurodevelopment

Infant Pain

Treatments

Drug: Dexmedetomidine Injectable Solution

Drug: Glucose 5% Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT07493785

DIVINEO

Details and patient eligibility

About

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.

Enrollment

246 estimated patients

Sex

All

Ages

Under 10 weeks old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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