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

NCT ID: NCT01266252

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-28
• Study Completion Date: 2018-04-10

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koenraad Smets, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

AZ Bruges

Bruges, , Belgium

Ghent University Hospital

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

Related Info

Other Identifiers

EC/2010/786

Identifier Type: -

Identifier Source: org_study_id