Status:
UNKNOWN
Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia
Lead Sponsor:
University of Sarajevo
Collaborating Sponsors:
KU Leuven
Amsterdam UMC, location VUmc
Conditions:
Asphyxia Neonatorum
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief 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 therape...
Detailed Description
Step 1: Retrospective evaluation of amikacin TDM in asphyxiated neonates treated with hypothermia (University hospital Leuven, VUmc Amsterdam) 1.1 Study patients All neonates admitted to the NICUs of...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Inclusion criteria for hypothermia group (University Clinical Centre Sarajevo)
- signed parental informed written consent
- newborn with GA ≥36 weeks
- newborn to whom amikacin is administered by intravenous route for clinical indications
- newborn with perinatal asphyxia treated with hypothermia
- Inclusion criteria for control group (University Clinical Centre Tuzla)
- signed parental informed written consent
- newborn to whom amikacin is administered by intravenous route for clinical indications
- newborn with GA ≥36 weeks
- newborn with perinatal asphyxia defined following Bristol hypothermia protocol from 2015
- Apgar score of ≤5 at 10 minutes after birth OR
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 min after birth OR
- Acidosis defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 min of birth pH\<7.00 OR
- Base deficit ≥-16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
- Non-inclusion criteria for both groups
- no parental informed consent
- the presence of congenital hepatic or renal pathology
- no central venous or arterial line in situ for non-invasive blood sampling procedures
- Exclusion criteria for both groups
- parental informed consent withdrawal
- the occurrence of clinical reasons to stop blood sampling
Exclusion
Key Trial Info
Start Date :
August 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04867993
Start Date
August 28 2018
End Date
December 1 2022
Last Update
April 30 2021
Active Locations (1)
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1
Pediatric Clinic, University Clinical Centre Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000