NCT01266252

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

Dexmedetomidine Pharmacokinetics - Pharmacodynamics in Mechanically Ventilated Neonates With Single-organ Respiratory Failure (NEODEX).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

Clinical experience with dexmedetomidine in the paediatric population is limited. Critical illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.

Detailed description

Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (\<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric population is limited. Moreover, during childhood many developmental changes take place with consequences on drug exposure and drug response. Finally, critical illness itself can affect drug pharmacokinetics and -dynamics. Therefore, the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.

Conditions

• Mechanically-ventilated Neonates With Single-organ Respiratory Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-28
• Primary completion: 2017-04-20
• Completion: 2018-04-10
• First posted: 2010-12-24
• Last updated: 2019-03-19

Locations

3 sites across 1 country: Belgium