Presepsin to Safely Reduce Antibiotics in Preterm Infants (PRESAFE)
Early-Onset Neonatal Sepsis
About this trial
This is an interventional diagnostic trial for Early-Onset Neonatal Sepsis focused on measuring preterm infants, antibiotics, presepsin
Eligibility Criteria
Inclusion Criteria: Infants born at a gestational age of 24+0 to 31 6/7 weeks Moderate risk of early-onset neonatal sepsis, i.e. infants who should be treated with empirical antibiotics based on the Dutch EOS guideline. Exclusion Criteria: low risk of early-onset neonatal sepsis who do not have an indication for empirical antibiotics according to the Dutch EOS guideline; high risk of early-onset neonatal sepsis defined as: suspected or confirmed diagnosis of maternal sepsis; suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection; unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2>0.40 or non-invasive ventilation with FiO2 >0.60 at time of randomization; ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization; strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Presepsin-guided therapy
Standard care
The decision to start empirical antibiotics in this group will be based on presepsin measurement within four hours after birth. When the presepsin value is above the cut-off value of 645 pg/ml, antibiotics will be ordered and administered within 4 hours of life and discontinued following the criteria of the Dutch EOS guideline. When the presepsin level is below the cut-off value of 645 pg/ml, the treating physician will not start antibiotic treatment. These infants will be closely observed for at least 72 hours. In case of deterioration of the clinical condition within this observation period, the clinician can decide to perform a sepsis evaluation and start with antibiotic treatment.
Standard care according to the Dutch EOS guideline. Presepsin will be determined with the treating physician blinded for the test result. In the Dutch EOS guideline maternal and neonatal risk factors for EOS are categorized as red flags or minor criteria. In the presence of 1 red flag or ≥ 2 minor criteria it is advised to perform a blood culture (= sepsis evaluation) and start empirical antibiotics for EOS suspicion. Antibiotic treatment will be advised to discontinue when blood culture turns back negative, reassuring the infants clinical condition with no other indicators of possible infection (e.g. CRP).