Effects of morphine and midazolam on sedation in neonates on mechanical ventilation
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 20 Weeks to 45 Weeks |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 5 sites (Brest and 4 other locations) |
| Trial ID | NCT05371886 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are under palliative care or have undergone recent surgical procedures may not benefit from this study.
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 performed: Other studies have explored similar pharmacokinetic and pharmacodynamic relationships in neonates, but this specific combination of drugs and methodology may provide novel insights.
Eligibility criteria
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 this trial is running
Brest and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.