Actively Recruiting
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-11-17
180
Participants Needed
5
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 undergoing mechanical ventilation, through PKPD modelling.
CONDITIONS
Official Title
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates younger than 45 weeks of corrected gestational age
- Hospitalized in a Neonatal Intensive Care Unit
- Undergoing mechanical ventilation
- Receiving morphine alone or morphine with midazolam as continuous infusion
- Affiliated to a social security system
You will not qualify if you...
- Current weight less than 600 grams
- Neonates under palliative care
- Receiving therapeutic hypothermia for perinatal anoxia
- Underwent a surgical procedure during the past 72 hours
- Receiving paralytic or other sedation or analgesia drugs besides morphine or midazolam (except paracetamol/acetaminophen)
- Parents refuse participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
CHRU Morvan
Brest, France, 29609
Actively Recruiting
2
CH SUD Francilien
Corbeil-Essonnes, France, 91100
Actively Recruiting
3
CHI Créteil
Créteil, France, 94000
Actively Recruiting
4
CHU Lille
Lille, France
Actively Recruiting
5
CHU Tours
Tours, France
Actively Recruiting
Research Team
M
Manon TAUZIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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