Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia (Amicool)
Asphyxia Neonatorum
About this trial
This is an interventional treatment trial for Asphyxia Neonatorum focused on measuring Amikacin, Pharmacokinetics, Hypothermia, Newborn
Eligibility Criteria
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
Sites / Locations
- Pediatric Clinic, University Clinical Centre SarajevoRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
asphyxiated neonates treated with amikacin and hypothermia
asphyxiated neonates treated with amikacin
Amikacin (Likacin®; 500 mg/2mL vial; Lisapharma S.p.A., Erba, Italy) is given to the neonate, as an IV infusion via umbilical vein over 20 min by use of a syringe-pump (Braun; B. Braun Medical Inc., Bethlehem, PA USA). Infusion is followed by slow 0.5 mL Sodium chloride 0.9% flush.
Amikacin (Likacin®; 500m g/2mL vial; Lisapharma S.p.A., Erba, Italy) is given to the neonate, as an IV infusion via umbilical vein over 20 min by use of a syringe-pump (Braun; B. Braun Medical Inc., Bethlehem, PA USA). Infusion is followed by slow 0.5 mL Sodium chloride 0.9% flush.