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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 5 sitesv9
  2. Study completion date: Jul 1, 2025 to May 1, 2027v8
  3. Study sites: 3 to 5v7
  4. Re-verified, no change to tracked fieldsv6
  5. Site details revised at 1 of 3 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v4
  2. Primary completion date: Dec 1, 2024 to Jul 1, 2023
    • Start date: Sep 1, 2022 to Apr 1, 2023
    • Study completion date: Dec 1, 2024 to Jul 1, 2025
    v3
  3. Start date: Jun 1, 2022 to Sep 1, 2022
    • Primary and study completion dates: Oct 1, 2024 to Dec 1, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05371886
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions
(from sponsor)		 Sedation Complication, Mechanical Ventilation in Neonates
Related terms Agnosia
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov