Completed

NCT Number: NCT01266252

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

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.

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Key information

Conditions

Mechanically-ventilated Neonates With Single-organ Respiratory Failure

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AZ Bruges, Bruges, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

pharmacokinetic parameters

Time frame: 72 hours

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

Time frame: 72 hours

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

Secondary outcomes

level of analgosedation

Time frame: 72 hours

Preliminary knowledge on the level of analgosedation provided by dexmedetomidine.
safety issues

Time frame: 72 hours

Preliminary knowledge of safety issues concerning systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation, temperature are assessed baseline and at least per hour reassessed after starting the dexmedetomidine infusion.
variability due to the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype

Time frame: 72 hours

Knowledge of the contribution of the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype (covariate) to the variability in exposure and response to dexmedetomidine.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

Orion Corporation, Orion Pharma

Registry information

Official study title

Dexmedetomidine Pharmacokinetics - Pharmacodynamics in Mechanically Ventilated Neonates With Single-organ Respiratory Failure (NEODEX).

Acronym: NEODEX

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2018
First posted: Dec 24, 2010
Registry last updated: Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.