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

• Status: Completed
• Trial end date: 2018-04-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• patient age less than 1 month (Male/Female) (step-down strategy for age)

• first included patients (n=30): postmenstrual age >= 34 weeks (near-term neonates)

• following included patients (n=30) : postmenstrual age >= 25 weeks and < 34 weeks (preterm neonates)

• patients with single-organ respiratory failure in need for analgosedation (guidance :

Comfort neo score >14 or Numeric Rating Scale (NRS) score Pain (P)/Comfort (C)>4)

• patients admitted to the neonatal intensive care unit

• expected to require at least 20 hours of mechanical ventilation

Exclusion Criteria:

• patients with neurologic conditions that prohibit an evaluation of adequate analgosedation

• no arterial catheter in place at inclusion

• patients who have received another investigational drug within 30 days

• patients on continuous infusion with neuromuscular blockers

• patients with a life expectancy <72 hours

• patients with a known allergy to fentanyl

• congenital or acquired heart block (grade 3)

• sustained bradycardia

• haemodynamically unstable patients (definition : Mean Arterial Pressure (MAP) lower than : postmenstrual age (in weeks) - 5 millimeter Hg, eventually under dopamine infusion max. 16 mcg/kilogram/minute and/or dobutamine infusion maximal 16 mcg/kilogram/minute)

• patients with significant renal insufficiency (creatinine plasma level >1.5 milligram/deciliter)

• patients with significant hepatic insufficiency (as estimated by local investigators)

• previous treatment with α2-adrenoreceptor agonist clonidine within 14 days

• absence of parental consent