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NCT05371886 | Recruiting | Sedation Complication

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

Creteil Intercommunal Hospital Center

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.

Condition or disease

Sedation Complication

Mechanical Ventilation in Neonates

Intervention/treatment

Dose-effect relationship of morphine +/- midazolam administration

Phase

Not Applicable

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.).}}

Study Type : Interventional
Estimated Enrollment : 180 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2025
Arm Intervention/treatment

Other: Dose-effect relationship of morphine +/- midazolam administration

Other: Dose-effect relationship of morphine +/- midazolam administration
Ages Eligible for Study: 20 Weeks to 45 Weeks
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

France,

CHRU Morvan

Brest, France, 29609

Not yet recruiting

France,

CH SUD Francilien

Corbeil-Essonnes, France, 91100

Recruiting

France,

CHI Créteil

Creteil, France, 94000