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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Veldhoven, , Netherlands
Amsterdam, , Netherlands
Rotterdam, , Netherlands
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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