NCT05796115

PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: University of Florence · Academic / Other
• Sex: All
• Age: 0 Hours – 3 Hours
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS). The main question it aims to answer is: • Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH \>3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS. Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight \<1500 g will be eligible for enrollment in the study. Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).

Conditions

• Early-Onset Neonatal Sepsis

Interventions

Type	Name	Description
PROCEDURE	Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS	Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life.
PROCEDURE	Antibiotic prophylaxis for EOS	Infants will receive antibiotic prophylaxis for EOS.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-03-31
• Completion: 2025-09-30
• First posted: 2023-04-03
• Last updated: 2023-04-03