Dexmedetomidine for Invasive Ventilation In the NEOnate

Phase 3Not Yet RecruitingNCT07493785

Centre Hospitalier Intercommunal Creteil246 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

246

Conditions

Invasive Ventilation

Eligibility

Sex: ALLMax age: 10 Weeks

Medical Language ↔ Plain English

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

Locations (12)

CHU Brest - Hôpital Morvan

Brest, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

CHU Grenoble Alpes

Grenoble, France

CHRU Lille

Lille, France

CHU Limoges

Limoges, France

CHU de Nantes

Nantes, France

CHU de Nice

Nice, France

AP-HP Hôpital Necker Enfants Malades

Paris, France

Hôpital NOVO - Site de Pontoise

Pontoise, France

Centre Hospitalier de Saint -Denis

Saint-Denis, France

...and 2 more locations

Outcomes

Primary Outcomes

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.