Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT04867993
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Day
Study:
NCT04867993
Study Brief:
Protocol Section:
NCT04867993