Dexmedetomidine for Neonatal respiratory distress | Neonatal pain and discomfort

Inclusion criteria

• {"criterion_text":"- Neonates with a gestational age at birth < 32 weeks of gestation and corrected gestational age < 32 weeks postmenstrual age\n- Invasively ventilated with an expected or effective duration of ventilation > 24h at inclusion\n- Under mechanical ventilation since less than 72h at inclusion\n- With parental consents\n- Affiliated to or benefiting from a social security system"}

Exclusion criteria

• {"criterion_text":"- Previous inclusion in this trial\n- Participation in another trial including analgesics or sedatives\n- Ongoing palliative care\n- Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours\n- 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\n- Pulmonary hypertension requiring pharmacological treatment\n- Heart rate <100 bpm\n- Hepatic impairment defined as alanine aminotransferase level > 2x normal upper limit\n- Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event\n- Hypersensitivity to the active substance or to any of the excipients contained in the medicine"}

Primary endpoints

• {"endpoint_text":"- 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 h, whichever comes last.","definition_or_measurement_approach":"Cumulative opioids (morphine, sufentanil, fentanyl) converted to morphine equivalents in µg/kg using fixed equipotency ratios based on national prescription habits; period = from start of investigational drug to cessation of any opioid or investigational drug for ≥24 h, whichever occurs last."}

Secondary endpoints

• {"endpoint_text":"- Pain and comfort outcomes: COMFORTneo pain and comfort scale, number of days with opioids and/or benzodiazepines, cumulative dose of midazolam (µg/kg), frequency of muscle blocker use;","definition_or_measurement_approach":"Measured by COMFORTneo scale, counts of days with opioids/benzodiazepines, cumulative midazolam dose (µg/kg), and frequency of muscle blocker use."}
• {"endpoint_text":"- Opioids’ adverse effects: age at full enteral feeding, urinary retention, Finnegan neonatal withdrawal scale, duration of invasive ventilation, extubation failure at 3 and 7 days after extubation, unplanned extubation","definition_or_measurement_approach":"Assessment of opioid-related adverse effects including age at full enteral feeding, urinary retention, Finnegan withdrawal scores, duration of invasive ventilation, extubation failure at 3 and 7 days, and unplanned extubation events."}
• {"endpoint_text":"- Dexmedetomidine’s tolerance: bradycardia (heart rate < 100/min for 5 consecutive minutes with SpO2> lower threshold for postmenstrual age), hypotension (mean arterial blood pressure in mmHg < postmenstrual age in weeks), anti-hypotensive treatments use","definition_or_measurement_approach":"Tolerance assessed by incidence of bradycardia defined as HR <100/min for 5 consecutive minutes with adequate SpO2, hypotension defined as MAP in mmHg < postmenstrual age in weeks, and use of anti-hypotensive treatments."}
• {"endpoint_text":"- Safety outcomes at discharge: in-hospital mortality, total duration of invasive and non-invasive ventilation, total duration of NICU and hospital stay, high-grade intraventricular hemorrhage, periventricular leukomalacia, secondary sepsis, treated patent ductus arteriosus, bronchopulmonary dysplasia at 36 weeks postmenstrual age, necrotizing enterocolitis, isolated intestinal perforation, treated retinopathy of prematurity.","definition_or_measurement_approach":"Safety assessed at discharge by in-hospital mortality and specified clinical complications and total durations of ventilation and hospital/NICU stay."}
• {"endpoint_text":"- Long-term neurodevelopment using tests validated in French: Parent Report of Children's Abilities-Revised (PARCA-R) at age 2 and BMT-i (Batterie Modulable de Tests informatisée, or \"computerized Adaptable Test Battery\") at age 6","definition_or_measurement_approach":"Long-term neurodevelopmental assessment using PARCA-R at age 2 and BMT-i at age 6 (tests validated in French)."}

France

Earliest CTIS Part Ii Submission Date

05-12-2025

Latest Decision Or Authorization Date

18-02-2026

Processing Time Days

75

Number Of Sites

12

Number Of Participants

246

Primary sponsor

Full Name

Centre Hospitalier Intercommunal Creteil

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France