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

PHASE1TerminatedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

January 23, 2018

Study Completion Date

January 23, 2018

Conditions
Anesthesia Intubation ComplicationPremature Birth of NewbornOther Preterm InfantsPropofol Overdose
Interventions
DRUG

Propofol

Propofol, an anesthetic agent, is used to sedate the patients before endotracheal intubation. The propofol starting dose in all age groups will be 1.0 mg propofol/kg. After 5 patients per age group the next dose will be determined. Dose will be increased or decreased with 0.5 mg/kg for the next 5 patients. The study will be continued untill an adequate dose, that results in adequate sedation, good intubation conditions without hypotension, is determined. That dose will be valideted in another 5 patients per age group.

Trial Locations (3)

1081HZ

VU Medical Center, Amsterdam

3000CB

Erasmus MC Sophia Children's Hospital, Rotterdam

5504 DB

Maxima Medisch Centrum, Veldhoven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amsterdam UMC, location VUmc

OTHER

collaborator

Maxima Medical Center

OTHER

collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Stichting Nuts Ohra

OTHER

lead

Erasmus Medical Center

OTHER

NCT02040909 - Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation | Biotech Hunter | Biotech Hunter