Actively Recruiting

Phase Not Applicable
Age: 20Weeks - 45Weeks
All Genders
NCT05371886

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

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Weeks - 45Weeks
All Genders

Eligibility Criteria

Eligible

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 with midazolam as continuous infusion
  • Affiliated to a social security system
Not Eligible

You will not qualify if you...

  • Current weight less than 600 grams
  • Neonates under palliative care
  • Receiving therapeutic hypothermia for perinatal anoxia
  • Underwent a surgical procedure during the past 72 hours
  • Receiving paralytic or other sedation or analgesia drugs besides morphine or midazolam (except paracetamol/acetaminophen)
  • Parents refuse participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

M

Manon TAUZIN, MD

CONTACT

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