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El ensayo clínico NCT07493785 para Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment, Insuficiencia respiratoria neonatal está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Dexmedetomidine for Invasive Ventilation In the NEOnate Fase II, Fase III 246 No invasivo Pediátrico
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El ensayo clínico NCT07493785 está diseñado para estudiar el tratamiento de Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment, Insuficiencia respiratoria neonatal. Este es un estudio intervencionista de Fase II Fase III. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de junio de 2026 hasta completar 246 participantes. Dirigido por Centre Hospitalier Intercommunal Creteil, se espera que finalice el 1 de agosto de 2034. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
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 frequen...
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Double Blind, Multicenter, Randomized, Controlled Trial of Dexmedetomidine vs Placebo in Premature Neonates Receiving Invasive Ventilation
Condiciones médicas
Invasive VentilationInfant PainInfant DiscomfortInfant NeurodevelopmentInsuficiencia respiratoria neonatalOtros ID del estudio
- DIVINEO
Número del NCT
Inicio del estudio (real)
2026-06-01
Última actualización
2026-03-25
Fecha de finalización (estimada)
2034-08-01
Inscripción (prevista)
246
Tipo de estudio
Intervencionista
FASE
Fase II
Fase III
Fase III
Estado general
Aún no recluta
Palabras clave
Neonatology
Invasive mechanical ventilation
Analgesia
Dexmedetomidine
Neurodevelopment
Opioids
Pain
Withdrawal syndrome
Invasive mechanical ventilation
Analgesia
Dexmedetomidine
Neurodevelopment
Opioids
Pain
Withdrawal syndrome
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Triple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalDexmedetomidine | Dexmedetomidine Injectable Solution Intravenous administration for maximum 20 days |
Comparador placeboGlucose 5% | Glucose 5% Injectable Solution Intravenous administration for maximum 20 days |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Percentage of time (hours) spent within an excessive/appropriate/ insufficient comfort/analgesia state based on the COMFORTneo scale | Scores of COMFORTneo scale :
* excessive: score \<11
* appropriate: score between 11 to 13
* insufficient : score \>13 | 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 | |
Frequency of muscle blocker use to improve ventilation | Number of patients receiving muscle bocker | 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 |
Rate of extubation failure | Number of reintubation within 7 days after the first planned extubation | Within 7 days after the first planned extubation |
Rate of unplanned extubation | 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 | |
Age at full enteral feeding in postmenstrual age (weeks) | To respond to the secondary objective : frequency of opioid-related adverse effects | From inclusion to hospital discharge, assessed up to 24 weeks |
Frequency of urinary retention episodes | To respond to the secondary objective : frequency of opioid-related adverse effects | 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 |
Finnegan neonatal withdrawal scale or any other validated withdrawal scale | To respond to the secondary objective : frequency of opioid-related adverse effects | Within 7 days of the first planned extubation or unplanned extubation lasting at least 24 hours |
Number of Bradycardia episodes | Heart rate \< 100/min for 5 consecutive minutes | 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 hypotension episodes | Mean arterial blood pressure in mmHg \< postmenstrual age in weeks. | 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 |
Frequency of anti-hypotensive treatments use | Volume expansion (at least 10 ml/kg), dopamine, dobutamine, epinephrine, norepinephrine, milrinone or hydrocortisone for hemodynamic support. | 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 In-hospital deaths | At 36 weeks postmenstrual age | |
Number of In-hospital deaths | From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks | |
Total duration of invasive ventilation | Number of days | From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Total duration of non-invasive ventilation | Number of days | From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Total duration of NICU stays | Number of days | From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Total duration Hospital stay | Number of days | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patients presenting high-grade intraventricular hemorrhage Grade 3 and 4 | To respond secondary objective of neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patients presenting periventricular leukomalacia | To respond secondary objective of severe neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patients presenting secondary sepsis | To respond secondary objective of severe neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patientsTreated for patent ductus arteriosus | To respond secondary objective of severe neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patients presenting bronchopulmonary dysplasia | To respond secondary objective of severe neonatal morbidities | At 36 weeks postmenstrual age |
Number of patients presenting necrotizing enterocolitis | To respond secondary objective of severe neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patients presenting isolated intestinal perforation | To respond secondary objective of severe neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Number of patients presenting treated retinopathy of prematurity | To respond secondary objective of severe neonatal morbidities | From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks |
Long-term neurodevelopment using tests validated in French : Parent Report of Children's Abilities-Revised (PARCA-R) | Higher scores indicate improved neurodevelopment | At 2 years corrected age +/- 2 months |
Long-term neurodevelopment using tests validated in French : BMT-i (Batterie Modulable de Tests informatisée, or "computerized Adaptable Test Battery") | Higher scores indicate improved neurodevelopment | At age 6 years +/- 2 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño
Criterios de sexo
Todos
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
- 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
Centre Hospitalier Intercommunal CreteilPr Xavier DURRMEYERContactos centrales del estudio
Contacto: Xavier DURRMEYER, MD, PhD, 0157023468, [email protected]
Contacto: Manon TAUZIN, MD, 0157022000, [email protected]
12 Centros del estudio en 1 países
CHU Brest - Hôpital Morvan, Brest, 29609, France
Jean Michel ROUE, PhD, Contacto, [email protected]
Centre Hospitalier Intercommunal de Créteil, Créteil, 94000, France
Manon TAUZIN, MD, Contacto, 0157022000, [email protected]
CHU Grenoble Alpes, Grenoble, 38700, France
Marie CHEVALLIER, PhD, Contacto, [email protected]
CHRU Lille, Lille, 59000, France
Riadh BOUKHRIS, MD, Contacto, [email protected]
CHU Limoges, Limoges, 87042, France
Laure PONTHIER, PhD, Contacto, [email protected]
CHU de Nantes, Nantes, 44000, France
Noura ZAYAT, MD, Contacto, [email protected]
CHU de Nice, Nice, 6200, France
Isabelle GUELLEC, PhD, Contacto, [email protected]
AP-HP Hôpital Necker Enfants Malades, Paris, 75015, France
Elsa KERMORVANT, PhD, Contacto, [email protected]
Hôpital NOVO - Site de Pontoise, Pontoise, 95300, France
Suzanne BORRHOMEE, MD, Contacto, [email protected]
Centre Hospitalier de Saint -Denis, Saint-Denis, 93200, France
Saba SALIBA, MD, Contacto, [email protected]
CHU Félix Guyon (Saint Denis), Saint-Denis, 97400, France
Anthony GRONDIN, MD, Contacto, [email protected]
CHU de La Réunion - Site Sud Saint-Pierre, Saint-Pierre, 97400, France
Silvia IACOBELLI, PhD, Contacto, [email protected]