Status:
RECRUITING
Presepsin to Safely Reduce Antibiotics in Preterm Infants
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Early-Onset Neonatal Sepsis
Eligibility:
All Genders
Phase:
NA
Brief Summary
In the Netherlands, more than 85% of the preterm infants born \<32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria. However, only 1 in 70 of...
Detailed Description
STUDY POPULATION All infants born at a gestational age of 24+0 to 31 6/7 weeks are eligible for enrollment. As part of standard care all infants will be screened and classified according to the Dutch...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06100614
Start Date
September 23 2024
End Date
January 1 2027
Last Update
October 2 2025
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105 AZ