Intransal pharmacokinetics of dexmedetomidine in preterm newborns

Intranasal dexmedetomidine: pilot pharmacokinetics / pharmacodynamics (PK/PD) study in a preterm population undergoing percutaneous central venous catheter placement - Pharmacokinetics of dexmedetomidine in preterm infants via the intranasal route

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000801-25-IT

Enrollment

Registered

2021-10-12

Start date

2021-12-10

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Preterm newborns of less than/or equal to 36 weeks of gestational age who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC). MedDRA version: 21.1 Level: LLT Classification code 10049124 Term: Sedation during medical procedure System Organ Class: 100000004865

Interventions

Trade Name: Dexdor Product Name: DEXDOR Product Code: [041468024] Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: DEXMEDETOMIDINA CLORIDRATO Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gestational age from 28 to 36 weeks with a minimum weight of 1 kg (50° percentile at 28 weeks of GA) 2. Patent umbilical catheter already in place (venous or arterial) 3. Need for a percutaneous venous catheter for nutritional and/or therapeutic purposes in elective conditions 4. Consent to the study participation and to the off-label use of dexmedetomidine 5. Drug therapies not included in the exclusion criteria Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1. Need for a percutaneous venous catheter in emergency conditions 2. Cardiac instability (such as arrhythmias or significant cardiac dysfunctions), hemodynamically significant congenital heart disease 3. Bradycardia at the time of enrolment with HR 100 U/L; ALT > 80 U/L; BD > 2 mg/dL or >20% of total bilirubin

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the pharmacokinetics of intranasal dexmedetomidine (after a dose of 3 µg/kg), in preterm babies of less than/or equal to 36 weeks of gestational age, who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC). The umbilical catheters will be used for serial blood micro-sampling, thus avoiding additional pain.;Secondary Objective: To define the clinical efficacy (sedation / pain reduction) of dexmedetomidine using the PIPP-R scale (Premature Infant Pain Profile- Revised) during the insertion of a percutaneous venous catheter.;Primary end point(s): The aim of the study is to define the pharmacokinetics of dexmedetomidine, administered intranasally, in preterm infants.;Timepoint(s) of evaluation of this end point: 12 hours	—

Measure

Time frame

Main Objective: To define the pharmacokinetics of intranasal dexmedetomidine (after a dose of 3 µg/kg), in preterm babies of less than/or equal to 36 weeks of gestational age, who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC). The umbilical catheters will be used for serial blood micro-sampling, thus avoiding additional pain.;Secondary Objective: To define the clinical efficacy (sedation / pain reduction) of dexmedetomidine using the PIPP-R scale (Premature Infant Pain Profile- Revised) during the insertion of a percutaneous venous catheter.;Primary end point(s): The aim of the study is to define the pharmacokinetics of dexmedetomidine, administered intranasally, in preterm infants.;Timepoint(s) of evaluation of this end point: 12 hours

—

Secondary

Measure	Time frame
Secondary end point(s): - The clinical efficacy of the drug (pharmacodynamics) expressed by the score of the PIPP scale, assessed during the procedure according to the blood concentration of the drug; The variation of vital parameters (heart rate, oxygen saturation, blood pressure) associated with the concentration of the drug;Timepoint(s) of evaluation of this end point: 30 minutes; 12 hours	—

Countries

Italy

Contacts

Public ContactSCR Epidemiologia e Biostatistica

IRCCS Burlo Garofolo di Trieste

segreteria.irb@burlo.trieste.it0403785411

Outcome results

None listed

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