Intransal pharmacokinetics of dexmedetomidine in preterm newborns

Phase 1

• 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: 21.1Level: LLTClassification code 10049124Term: Sedation during medical procedureSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2021-000801-25-IT
• Lead Sponsor: IRCCS MATERNO INFANTILE BURLO GAROFOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-12
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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

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
4. Hypotension at the time of enrolment with mean BP less than GA
5. Beta blocker or digoxin therapy or drugs acting on the atrio-ventricular node
6. IVH 3-4
7. Administration of sedative or anaesthetic drugs in the 8 hours prior to enrolment
8. Any nasal obstruction that might impair the intranasal drug administration/absorption
9. Craniofacial anomalies associated with difficulty in ventilation through a mask or intubation
10. Liver disease characterised by AST > 100 U/L; ALT > 80 U/L; BD > 2 mg/dL or >20% of total bilirubin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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