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Presepsin to Safely Reduce Antibiotics in Preterm Infants

RecruitingNAAges any - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT06100614 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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: 1. suspected or confirmed diagnosis of maternal sepsis; 2. suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection; 3. unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2\>0.40 or non-invasive ventilation with FiO2 \>0.60 at time of randomization; 4. ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization; 5. strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone).
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What it tests

  • Presepsin
  • Standard Care
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Where

1 site
Amsterdam UMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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