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Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care

RecruitingNAAges 20 Weeks - 45 WeeksAllCentre Hospitalier Intercommunal Creteil
NCT05371886 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Dose-effect relationship of morphine +/- midazolam administration
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Where

5 sites
CHRU Morvan
Brest, France
CH SUD Francilien
Corbeil-Essonnes, France
CHI Créteil
Créteil, France
CHU Lille
Lille, France
CHU Tours
Tours, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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