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RecruitingNot ApplicableNCT05371886

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

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

180 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Sedation ComplicationMechanical Ventilation in Neonates

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 undergoing mechanical ventilation, through PKPD modelling.

Eligibility

Min Age: 20 WeeksMax Age: 45 Weeks

Inclusion Criteria5

  • 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 Criteria6

  • 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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Interventions

OTHERDose-effect relationship of morphine +/- midazolam administration

Dose-effect relationship of morphine +/- midazolam administration as continuous infusion in neonates undergoing mechanical ventilation through PKPD modelling

Locations(5)

CHRU Morvan

Brest, France

CH SUD Francilien

Corbeil-Essonnes, France

CHI Créteil

Créteil, France

CHU Lille

Lille, France

CHU Tours

Tours, France

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NCT05371886

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