Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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)
Phase:
N/A
Details
Lead Sponsor:
University of Sarajevo
Collaborators:
KU Leuven Leiden University Medical Center University Clinical Center Tuzla VU University Medical Center