Status:
RECRUITING
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Conditions:
Sedation Complication
Mechanical Ventilation in Neonates
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and und...
Detailed Description
This study will include all neonates receiving a sedo-analgesia with continuous infusion of morphine alone or morphine and midazolam during mechanical ventilation in 3 French NICUs. Comfort and pain w...
Eligibility Criteria
Inclusion
- Neonates \< 45 weeks of corrected gestational age
- Hospitalized in a Neonatal Intensive Care Unit
- Undergoing mechanical ventilation
- Patients that receive morphine alone or morphine and midazolam as continuous infusion
- Affiliated to a social security system
Exclusion
- Current weight \< 600g
- Neonates under palliative care
- Therapeutic hypothermia for perinatal anoxia
- Neonates who underwent a surgical procedure during the past 72 hours
- Neonates receiving concomitantly a paralytic or another drug for sedation or analgesia other than morphine or midazolam (except for paracetamol/acetaminophen)
- Parents refusing that their child participate
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05371886
Start Date
April 1 2023
End Date
May 1 2027
Last Update
November 17 2025
Active Locations (5)
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1
CHRU Morvan
Brest, France, 29609
2
CH SUD Francilien
Corbeil-Essonnes, France, 91100
3
CHI Créteil
Créteil, France, 94000
4
CHU Lille
Lille, France