• Development of a Morphine Pharmacokinetic and Pharmacodynamic Model for the Neonatal Population

  NCT03035578

  WithdrawnInterventionalPhase 1Phase 2Updated Feb 25, 2020
• Study of Morphine in Postoperative Infants to Allow Normal Ventilation

  NCT00004696

  CompletedInterventionalNot ApplicableUpdated Mar 25, 2015
• Optimizing the Use of Morphine in Pre-Term Neonates

  NCT00494429

  CompletedInterventionalPhase 2Updated Jul 27, 2016
• Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.

  NCT01094522

  CompletedInterventionalPhase 1Phase 2Updated Sep 18, 2017
• Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome

  NCT00391105

  CompletedInterventionalPhase 4Updated Oct 23, 2006
• Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

  NCT01823497

  CompletedInterventionalNot ApplicableUpdated Sep 2, 2020

ClinicalTrials.gov ID

NCT05371886

Lead Sponsor

Centre Hospitalier Intercommunal CreteilOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

180Estimated

Last Update Posted

Nov 17, 2025Actual

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jul 1, 2023Actual

Completion Date

May 1, 2027Estimated

Official Title

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

Brief 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.

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.).

• Sedation Complication
• Mechanical Ventilation in Neonates

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

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Supportive Care

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier Intercommunal CreteilOTHER

riadh.boukhris@chu-lille.fr

a.loose@chu-tours.fr