Mechanically-ventilated Neonates With Single-organ Respiratory Failure Clinical Trial
— NEODEXOfficial title:
Dexmedetomidine Pharmacokinetics - Pharmacodynamics in Mechanically Ventilated Neonates With Single-organ Respiratory Failure (NEODEX).
| Verified date | March 2019 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | April 10, 2018 |
| Est. primary completion date | April 20, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 1 Month |
| Eligibility |
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 a2-adrenoreceptor agonist clonidine within 14 days - absence of parental consent |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | AZ Bruges | Bruges | |
| Belgium | Ghent University Hospital | Ghent | |
| Belgium | UZ Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Orion Corporation, Orion Pharma |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pharmacokinetic parameters | Pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure. | 72 hours | |
| Primary | Covariates | Covariates contributing to a variability in exposure and response to dexmedetomidine. | 72 hours | |
| Secondary | level of analgosedation | Preliminary knowledge on the level of analgosedation provided by dexmedetomidine. | 72 hours | |
| Secondary | safety issues | 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. | 72 hours | |
| Secondary | variability due to the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype | 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. | 72 hours |