Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure. (NEODEX)
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|ClinicalTrials.gov Identifier: NCT01266252|
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mechanically-ventilated Neonates With Single-organ Respiratory Failure||Drug: Dexmedetomidine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dexmedetomidine Pharmacokinetics - Pharmacodynamics in Mechanically Ventilated Neonates With Single-organ Respiratory Failure (NEODEX).|
|Actual Study Start Date :||July 28, 2011|
|Actual Primary Completion Date :||April 20, 2017|
|Actual Study Completion Date :||April 10, 2018|
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.
- pharmacokinetic parameters [ Time Frame: 72 hours ]Pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure.
- Covariates [ Time Frame: 72 hours ]Covariates contributing to a variability in exposure and response to dexmedetomidine.
- level of analgosedation [ Time Frame: 72 hours ]Preliminary knowledge on the level of analgosedation provided by dexmedetomidine.
- safety issues [ Time Frame: 72 hours ]Preliminary knowledge of safety issues concerning systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation, temperature are assessed baseline and at least per hour reassessed after starting the dexmedetomidine infusion.
- variability due to the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype [ Time Frame: 72 hours ]Knowledge of the contribution of the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype (covariate) to the variability in exposure and response to dexmedetomidine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266252
|Bruges, Belgium, 8000|
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Principal Investigator:||Koenraad Smets, MD, PhD||University Hospital, Ghent|