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Search / Trial NCT02040909

Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation

Launched by ERASMUS MEDICAL CENTER · Jan 17, 2014

Trial Information

Current as of August 14, 2025

Terminated

Keywords

Sedation Quality Of Intubation Hypotension Pharmacodynamics Pharmacokinetics

ClinConnect Summary

Rationale: Propofol, a rapidly acting anaesthetic agent, is currently used unlicensed in the clinical care of (preterm) neonates as sedative for endotracheal intubation. Neonates receive the same propofol doses per kg bodyweight, independent of their developmental stage (gestational age, postnatal age), morbidity, co-medication, etc. This is related to a high failure rate of intubation attempts and leads to hypotension in around 40 percent of patients. Propofol research in newborn infants is on the recently published priority drug research list of the European Medicines Agency (EMA). Propof...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All neonates admitted to the two participating intensive care units:
  • Less than 28 days postnatal age
  • Who need endotracheal intubation
  • Exclusion Criteria:
  • Patients with:
  • Major congenital anomalies or neurological disorders,
  • Neonates with an abnormal upper airway,
  • Those receiving continuous sedatives or opioids, and
  • Those whose mothers received sedatives or opioids before or during delivery will be excluded during the first 2 days of life.

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Veldhoven, , Netherlands

Amsterdam, , Netherlands

Rotterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

Mirjam van Weissenbruch, MD PhD

Study Director

VU Medical Center Amsterdam

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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