Condition: Early-Onset Neonatal Sepsis · Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 these preterm babies actually has a bacterial infection. The use of antibiotics after birth can lead to problems on short term (bowel infection, infection with a bacteria later on or death) or long term (asthma, allergy, obesity). The goal of the PRESAFE trial is to investigate whether addition of a biomarker (presepsin) to the Dutch early-onset neonatal sepsis (EOS) guideline safely reduces unnecessary empirical antibiotic exposure after birth in preterm infants born before 32 weeks gestational age. In this 874-subject multicenter, randomized clinical trial with a concurrent observational cohort, the hypothesis to be tested is that by adding presepsin to the national guideline the amount of unnecessary empirical antibiotic exposure after birth will be reduced with at least 30% without increase in infants with untreated sepsis. The study targets a population of clinical stable very preterm infants with risk factors for eary-onset neonatal sepsis. Antibiotic administration after birth is started to pre-emptively treat EOS. By adding a presepsin-guided step to the Dutch EOS guideline for those infants qualifying for antibiotic treatment, it is assumed that the rate of antibiotic administration can be reduced. However, it is imperative that this reduction in antibiotics is not ou…
This description comes directly from the study's public registry record.
Douwe Visser, MD PhD · +31205669111 · d.h.visser@amsterdamumc.nl
Charlotte Nusman, MD PhD · +31205669111 · c.m.nusman@amsterdamumc.nl
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| Amsterdam UMC | Amsterdam, North Holland, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06100614