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

NCT01266252 | Completed Phase 3 DMC

• 1 other identifier: EC/2010/786
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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 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

Keywords

neonates; single organ respiratory failure

Outcome Measures

Primary Outcomes (2)

• pharmacokinetic parameters

  Pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure.

  72 hours

• Covariates

  Covariates contributing to a variability in exposure and response to dexmedetomidine.

  72 hours

Secondary Outcomes (3)

• level of analgosedation

  72 hours

• safety issues

  72 hours

• variability due to the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype

  72 hours

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (3)

AZ Bruges

Bruges, 8000, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Koenraad Smets, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 24, 2010
• Study Start: July 28, 2011
• Primary Completion: April 20, 2017
• Study Completion: April 10, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

BE (3)