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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2027-05-01

Brief Summary

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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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Detailed Description

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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.).

Conditions

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Sedation Complication Mechanical Ventilation in Neonates

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The main objective is to estimate a dose-effect relationship of morphine +/- midazolam administration as continuous infusion in neonates undergoing mechanical ventilation through PKPD modelling.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dose-effect relationship of morphine +/- midazolam administration

Group Type OTHER

Dose-effect relationship of morphine +/- midazolam administration

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Weeks

Maximum Eligible Age

45 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No