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
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how morphine alone and morphine combined with midazolam, given as a continuous infusion, affect newborns in neonatal intensive care units (NICUs) who require mechanical ventilation. The study aims to understand the relationship between drug dose, concentration in the body, and the resulting effect, including comfort and pain levels in these neonates. This research uses pharmacokinetic-pharmacodynamic (PKPD) modeling to describe these relationships and account for differences between individual babies based on factors like gestational age, post-natal age, and weight. The study includes neonates receiving continuous infusions of morphine alone or with midazolam during mechanical ventilation in three French NICUs. Comfort and pain are assessed using the COMFORTneo pain score and Newborn Infant Parasympathetic Evaluation (NIPE) Index. Blood samples taken during routine testing will measure morphine, midazolam, and their metabolites concentrations. Using PKPD modeling, researchers will analyze dose-effect and dose-concentration relationships and simulate the doses needed to maintain comfort in neonates. During the study, participants will have their pain and comfort levels regularly assessed while receiving morphine or morphine plus midazolam infusions for up to 20 weeks. Blood samples from planned tests will be analyzed for drug levels. The primary outcome is the effective dose for 50% of neonates (ED50) receiving morphine. Secondary outcomes include drug clearance, distribution volume, concentrations, dosing rates, and pain responses by the NIPE index. The study monitors these outcomes from inclusion until the end of treatment, helping to better understand dosing needs and effects in this vulnerable population.
CONDITIONS
Brief 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 and 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
- Neonates who had surgery within the past 72 hours
- Receiving paralytic or other sedation/analgesia drugs besides morphine or midazolam (except paracetamol/acetaminophen)
- Parents refusing their child to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From date of inclusion until the end of morphine +/- midazolam treatment, up to 20 weeks
Participants receive continuous infusion of morphine alone or morphine with midazolam during mechanical ventilation in the neonatal intensive care unit. Pain and comfort are assessed while drug concentrations are measured through planned blood tests.
Visits occur as needed for continuous infusion and planned blood sampling during treatment
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
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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