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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 3

Conditions

Mechanically-ventilated Neonates With Single-organ Respiratory Failure

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01266252

EC/2010/786

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

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