Dexmedetomidine pharmacokinetics-pharmacodynamics in mechanically ventilated neonates with single-organ respiratory failure

Dexmedetomidine pharmacokinetics-pharmacodynamics in mechanically ventilated neonates with single-organ respiratory failure (NEODEX)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023155-28-BE

Enrollment

Unknown

Registered

2010-12-20

Start date

2011-02-14

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients admitted to the neonatal intensive care unit with single-organ respiratory failure MedDRA version: 18.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848

Interventions

Trade Name: Dexdor 100 µg/ml Product Name: dexmedetomidine Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775476 Concentration unit: µg/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patient age less than 1 month (adaptive design:step-down strategy for age) - 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 or cardiac intensive care unit - expected to require at least 20 h of mechanical ventilation Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 1.5 mg/dl) - patients with significant hepatic insufficiency (as estimated by local investigators) - previous treatment with a2-adrenoreceptor agonist clonidine within 14 days - absence of parental consent

Design outcomes

Primary

Measure	Time frame
Main Objective: - what are the pharmacokinetic parameters (distribution volume, distribution half-life, terminal half-life, context-sensitive half-life, clearance) of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure? - do size, age (postmenstrual, postconceptional, postnatal), co-medication, severity of illness, infusion length (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - knowledge of the pharmacokinetic parameters of dexmedetomidine and their covariates will allow targeted dosing in this population ;Secondary Objective: - does CYP2A6 and UDP-glucuronosyltransferase genotype (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - describe the maturational trends in PK and PD in combining the observations in neonates with similar observations during childhood;Primary end point(s): PK analysis;Timepoint(s) of evaluation of this end point: Maximum 4 days.	—

Measure

Time frame

Main Objective: - what are the pharmacokinetic parameters (distribution volume, distribution half-life, terminal half-life, context-sensitive half-life, clearance) of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure? - do size, age (postmenstrual, postconceptional, postnatal), co-medication, severity of illness, infusion length (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - knowledge of the pharmacokinetic parameters of dexmedetomidine and their covariates will allow targeted dosing in this population ;Secondary Objective: - does CYP2A6 and UDP-glucuronosyltransferase genotype (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - describe the maturational trends in PK and PD in combining the observations in neonates with similar observations during childhood;Primary end point(s): PK analysis;Timepoint(s) of evaluation of this end point: Maximum 4 days.

—

Secondary

Measure	Time frame
Secondary end point(s): Vital signs.;Timepoint(s) of evaluation of this end point: At baseline and at least once every hour after start of dexmedetomidine.	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hostital

Bimetra.Clinics@uzgent.be3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026