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Recruiting NCT05371886

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

No phase Interventional Sedation Complication Mechanical Ventilation in Neonates

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dose-effect relationship of morphine +/- midazolam administration.
Who it may be relevant to
Registry conditions: Sedation Complication, Mechanical Ventilation in Neonates. Basic parameters: 20 Weeks — 45 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

This study will include all neonates receiving a sedo-analgesia with continuous infusion of morphine alone or morphine and midazolam during mechanical ventilation in 3 French NICUs. Comfort and pain will be assessed by COMFORTneo pain scores and Newborn Infant Parasympathetic Evaluation Index. Morphine, midazolam and their metabolites' concentrations will be determined on samples taken during a planned blood test. Through PKPD modelling, the dose-concentration-effect relationships will be found and interindividual variability of these drugs in neonates and simulate doses needed to achieve comfort in neonates according to their individual characteristics (gestational age, post-natal age, weight etc.).

Interventions

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

Primary outcome measures

  • Effective dose for 50% of patients (ED50 ) of morphine in continuous infusion in neonates ventilated in the neonatal intensive care unit [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]
Secondary outcome measures (6)
  • Clearance (ml/min/kg) of morphine and midazolam [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]
  • Volume of distribution (L/kg) of morphine and midazolam [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]
  • Concentration of morphine [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]
  • Concentration of midazolam [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]
  • Doses of morphine and midazolam (µg/kg/h) [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]
  • To assess pain responses by the Newborn Infant Parasympathetic Evaluation (NIPE) index [Time frame: From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 5 centers
  • CHRU Morvan — Brest
  • CH SUD Francilien — Corbeil-Essonnes
  • CHI Créteil — Créteil
  • CHU Lille — Lille
  • CHU Tours — Tours

Identifiers

NCT: NCT05371886 · PHARAONIC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗