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NCT05371886
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
NA trial testing Dose-effect relationship of morphine +/- midazolam administration in Sedation Complication in 180 participants. Currently enrolling.
1 July 2023
Quick facts
| Lead sponsor | Centre Hospitalier Intercommunal Creteil |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 180 |
| Start date | 1 April 2023 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 May 2027 |
| Sites | 5 locations across France |
Drugs / interventions tested
- Dose-effect relationship of morphine +/- midazolam administration
Conditions studied
- Sedation Complication — all drugs for Sedation Complication →
- Mechanical Ventilation in Neonates — all drugs for Mechanical Ventilation in Neonates →
Sponsor
Centre Hospitalier Intercommunal Creteil
Who can join
Adults 20 Weeks to 45 Weeks, any sex, with Sedation Complication or Mechanical Ventilation in Neonates. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05371886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sedation Complication
Currently open trials in the same condition.
- NCT06667869 — multipaRameter mOnitoring systeM for sedAtion iNThe ICu · recruiting
- NCT07456111 — A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy · Phase 4 · recruiting
- NCT06769308 — Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients · NA · recruiting
- NCT05765162 — Safe Brain Initiative, Operationalizing Precision Anaesthesia · recruiting
- NCT04801589 — Goal-Directed Sedation in Mechanically Ventilated Infants and Children · Phase 3 · recruiting
Other Centre Hospitalier Intercommunal Creteil trials
Trials by the same sponsor.
- NCT07493785 — Dexmedetomidine for Invasive Ventilation In the NEOnate · Phase 2, PHASE3 · not yet recruiting
- NCT07513051 — DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO) · NA · not yet recruiting
- NCT07455942 — Towards an Understanding of Barriers and Delays in the Diagnosis of Anal Cancer · not yet recruiting
- NCT07153367 — Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauter · Phase 2 · recruiting
- NCT06339450 — Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05371886 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Intercommunal Creteil
- Last refreshed: 17 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05371886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing