Status:
RECRUITING
Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator
Lead Sponsor:
prof. dr. Frans B. Plötz
Collaborating Sponsors:
Dutch Society of Pediatrics
Zorgevaluatie Nederland
Conditions:
Early-Onset Sepsis, Neonatal
EOS
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
Newborns are at risk for early-onset sepsis (EOS), which occurs within 72 hours after birth. The incidence of proven EOS is 0.5-2.0 per 1000 live births. The annual birth rate in the Netherlands is ar...
Detailed Description
Suspicion of EOS is often based on risk factors and nonspecific clinical symptoms, such as maternal fever during labor or rapid breathing in the newborn. The combination of the difficulty to recognize...
Eligibility Criteria
Inclusion
- 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
- major congenital anomalies;
- language barrier (lack of effective communication or whenever it hinders understanding).
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
1830 Patients enrolled
Trial Details
Trial ID
NCT05274776
Start Date
April 12 2022
End Date
October 1 2024
Last Update
February 1 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwest Clinics
Alkmaar, Netherlands
2
FlevoHospital
Almere Stad, Netherlands
3
Amstelland Hospital
Amstelveen, Netherlands
4
OLVG
Amsterdam, Netherlands