Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator
Early-Onset Sepsis, Neonatal, EOS
About this trial
This is an interventional treatment trial for Early-Onset Sepsis, Neonatal focused on measuring early-onset sepsis, neonatal, EOS calculator
Eligibility Criteria
Inclusion Criteria:
- postmenstrual age of 34 weeks or more;
- age between 0-24 hours;
- at least one EOS risk factor or clinical sign of infection (suspected of EOS) present within the first 24 hours of life;
- parental/guardian consent.
Exclusion Criteria:
- major congenital anomalies;
- language barrier (lack of effective communication or whenever it hinders understanding).
Sites / Locations
- Northwest ClinicsRecruiting
- FlevoHospitalRecruiting
- Amstelland HospitalRecruiting
- OLVGRecruiting
- Martini HospitalRecruiting
- Spaarne HospitalRecruiting
- Dijklander HospitalRecruiting
- Canisius-Wilhelmina HospitalRecruiting
- Máxima Medical CenterRecruiting
- Zaans Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
NVK Guidelines
EOS Calculator
The NVK guidelines use 8 maternal and 15 neonatal risk factors, each categorized as either red flag or non-red flag. These criteria guide clinicians on the management in case of suspected EOS. Briefly, antibiotic treatment is recommended if at least one red flag and, or, two or more non-red flags are present. An observation period of at least 12 hours is recommended if one non-red flag is present. Antibiotics are recommended when an infection is suspected during this observation. Newborns without EOS risk factors, with a good clinical condition, and a gestational age of more than 36 weeks will be discharged. If the guidelines recommend an observation period, the newborn with a good clinical condition is discharged after repeating physical examination. In case antibiotic treatment is started, discharge depends on the duration of treatment and the clinical course. At discharge, parents are instructed to call the hospital in case of signs of infection within the first 14 days of life.
Using the EOS calculator application between 0-24 hours after birth, maternal EOS risk factors combined with the physical examination of the newborn are used to assign a risk category and accompanying clinical recommendation based on estimated EOS incidence for each newborn at-risk for an infection. The EOS calculator results are used to guide clinical management on performing either a diagnostic work-up and start of antibiotics for (suspected) EOS, or a conservative approach with routine controls of vital parameters every 3 hours. In case of routine controls, re-evaluation of physical appearance by a pediatric resident or pediatrician will take place within 24 hours postpartum. Newborns will be observed for at least 24 hours. In case antibiotics are started, the need for further treatment is depending on blood culture results, infection parameters, and clinical condition of the newborn. Discontinuation of antibiotics and discharge is at the discretion of the treating physician.