Effects of morphine and midazolam on sedation in neonates on mechanical ventilation
Official title: Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
Run by Centre Hospitalier Intercommunal Creteil · NCT05371886 · Data updated 2026-11-12
This study tests how well morphine and midazolam work together to keep babies on breathing machines comfortable and pain-free in the intensive care unit.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Weeks to 45 Weeks |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 5 sites (Brest and 4 other locations) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | July 1, 2023 |
| Study ends | May 1, 2027 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT05371886 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates under 45 weeks of corrected gestational age who are hospitalized in a Neonatal Intensive Care Unit and undergoing mechanical ventilation.
✕Probably not a fit
Patients who are under palliative care or have undergone recent surgical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the pharmacokinetics and pharmacodynamics of morphine, both alone and in combination with midazolam, administered via continuous infusion to neonates in intensive care who are undergoing mechanical ventilation. It will assess the comfort and pain levels of these infants using specific scoring systems while measuring drug concentrations through blood tests. The goal is to establish a dose-effect relationship and understand the variability in drug response among neonates based on individual characteristics such as gestational age and weight.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation management in neonates, enhancing their comfort during mechanical ventilation.
How similar studies have gone: Other studies have explored similar pharmacokinetic and pharmacodynamic relationships in neonates, but this specific combination of drugs and methodology may provide novel insights.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
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
Study contacts
- Study coordinator: Manon TAUZIN, MD
- Email: manon.tauzin@chicreteil.fr
- Phone: 01 45 17 50 00
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This study is testing a new monitoring system that uses machine learning to see if it can better track sedation levels in critically ill patients in the ICU compared to standard methods.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.