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

Status: Unknown
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.

Contact Information
Primary
Carlo Dani
carlo.dani@unifi.it
0039 055 7948421
Time Frame
Start Date: 2023-04-01
Completion Date: 2025-09-30
Participants
Target number of participants: 266
Treatments
Active_comparator: Antibiotic prophylaxis for EOS
Experimental: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
Related Therapeutic Areas
Sponsors
Leads: University of Florence

This content was sourced from clinicaltrials.gov