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PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

NCT05796115 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2023-04-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
3 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-03-31
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796115 on ClinicalTrials.gov