Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure.

PHASE3CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 28, 2011

Primary Completion Date

April 20, 2017

Study Completion Date

April 10, 2018

Conditions
Mechanically-ventilated Neonates With Single-organ Respiratory Failure
Interventions
DRUG

Dexmedetomidine

"Dexmedetomidine will be given maximal 72 hours. In case analgosedation is still needed after stop of the dexmedetomidine infusion, the treatment is switched to conventional analgosedation regimens.~Additional drugs are given to every inadequately sedated-painful patient (assessed by regular Comfort-neo and Numeric Rating Scale scoring). In case of oversedation or adverse drug events (hypotension, bradycardia), a downtitration (or stop) of the dexmedetomidine infusion is needed."

Trial Locations (3)

8000

AZ Bruges, Bruges

9000

Ghent University Hospital, Ghent

Unknown

UZ Leuven, Leuven

All Listed Sponsors
collaborator

Orion Corporation, Orion Pharma

INDUSTRY

lead

University Hospital, Ghent

OTHER

NCT01266252 - Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure. | Biotech Hunter | Biotech Hunter