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Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia

NCT04867993 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-04-30

No results posted yet for this study

Summary

As a part of a project on perinatal clinical pharmacology, the primary aim of the present project is to study amikacin pharmacokinetics (PK) and physiology in asphyxiated neonates treated with therapeutic hypothermia and to provide amikacin dosing recommendations, which will be validated prospectively. For this purpose, we aim to first collect retrospective data on amikacin available in neonates treated with hypothermia in the neonatal intensive care unit (NICU)s in Leuven and Amsterdam, and consequently to propose the dosing regimen to be used in the prospective amikacin PK study at our NICU in University Clinical Center (UCC) Sarajevo. At our NICU we aim to collect amikacin PK observations and other covariates in at least 40 neonates while treated with hypothermia and after re-warming period (a paired analysis), and in asphyxiated neonates not treated with hypothermia (control group).

We hereby will use a stepwise approach, as initially used to develop and to validate an amikacin dosing regimen in preterm and term neonates (De Cock RFW et al., 2012, Smits A et al, 2015).

A 3-step approach will be used, of which different parts will be conducted in different contributing hospitals:

1. Retrospective evaluation of amikacin therapeutic drug monitoring (TDM) in asphyxiated neonates treated with hypothermia (University hospital Leuven, VUmc Amsterdam)
2. Development of population PK model derived amikacin dosing recommendation
3. Prospective PK study with validation of the new dosing regimen (UCC Sarajevo, UCC Tuzla)

Conditions

  • Asphyxia Neonatorum

Interventions

DRUG

Amikacin

15 mg/kg/36h

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • University Clinical Center Tuzla

    collaborator OTHER

  • University of Sarajevo

    lead OTHER

Principal Investigators

  • Karel Allegaert, MD PhD · Catholic University Leuven, Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2022-08-31
Completion
2022-12-31

Countries

  • Bosnia and Herzegovina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867993 on ClinicalTrials.gov