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

NCT05371886 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Intercommunal Creteil

Phase

Not applicable

Started

2023-04-01

Last updated

2025-11-17

Condition(s) studied

Sedation ComplicationMechanical Ventilation in Neonates

Investigational drug(s) / intervention(s)

Dose-effect relationship of morphine +/- midazolam administration

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

Study 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.

Eligibility

Sex

ALL

Min age

20 Weeks

Max age

45 Weeks

Healthy volunteers

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 outcome measure(s)

Effective dose for 50% of patients (ED50 ) of morphine in continuous infusion in neonates ventilated in the neonatal intensive care unit — From date of inclusion until the date of end of morphine +/- midazolam treatment, up to 20 weeks
To evaluate which dose is effective, cComfort will be assessed with COMFORTneo score (scale from 6 to 30 with decreasing score with increasing comfort). The dose-response relationship will be assessed with the correlation between a comfortable score (between 11 and 13) and the effective dose for 50% of patients (ED50), by PKPD modeling

Trial sites (5)

Facility	City	Region	Status
CHRU Morvan	Brest	France	Recruiting
CH SUD Francilien	Corbeil-Essonnes	France	Recruiting
CHI Créteil	Créteil	France	Recruiting
CHU Lille	Lille	France	Recruiting
CHU Tours	Tours	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05371886 on ClinicalTrials.gov ↗ ← All trials in France