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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Current weight < 600g

Neonates under palliative care

Therapeutic hypothermia for perinatal anoxia

Neonates who underwent a surgical procedure during the past 72 hours

Trial design

Treatments tested in this trial

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

Treatment groups

180 Participants
are divided into 1 treatment group