Status:
COMPLETED
Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure.
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Mechanically-ventilated Neonates With Single-organ Respiratory Failure
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
Brief 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 dat...
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 sedatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01266252
Start Date
July 28 2011
End Date
April 10 2018
Last Update
March 19 2019
Active Locations (3)
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1
AZ Bruges
Bruges, Belgium, 8000
2
Ghent University Hospital
Ghent, Belgium, 9000
3
UZ Leuven
Leuven, Belgium