NCT05371886 Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
| NCT ID | NCT05371886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | Sedation Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2023-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-04-01 with a primary completion date of 2023-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05371886 clinical trial?
This trial is open to participants of all sexes, aged 20 Weeks or older, up to 45 Weeks, studying Sedation Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05371886 currently recruiting?
Yes, NCT05371886 is actively recruiting participants. Contact the research team at manon.tauzin@chicreteil.fr for enrollment information.
Where is the NCT05371886 trial being conducted?
This trial is being conducted at Brest, France, Corbeil-Essonnes, France, Créteil, France, Lille, France and 1 additional location.
Who is sponsoring the NCT05371886 clinical trial?
NCT05371886 is sponsored by Centre Hospitalier Intercommunal Creteil. The trial plans to enroll 180 participants.