drugset / Trial / NCT00571636
Continuous Infusion of Fentanyl in Preterm on MV
Phase 3
Completed
128 enrolled
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agenzia Italiana del Farmaco · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA \<= 32 weeks in MV: * Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl; * Group B) continuous infusion of placebo + open label boluses of Fentanyl.
Timeline
- Start
- 2007-12
- Primary completion
- 2010-04
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 1 ug/kg | Intravenous |