PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

University of Florence266 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

266

Conditions

Early-Onset Neonatal Sepsis

Interventions

Eligibility

Sex: ALLMin age: 0 HoursMax age: 3 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study. Exclusion Criteria: * Risk factors for EOS: * maternal GBS colonization without adequate prophylaxis; * clinical chorioamnionitis diagnosed by maternal intrapartum fever (either a single documented maternal intrapartum temperature of ≥39.0°C or a temperature of 38.0-38.9°C that persists for \>30 minutes) and 1 or more of the following: (1) maternal leukocytosis, (2) purulent cervical drainage, and (3) fetal tachycardia; * pre-labor rupture of membranes (ROM) \>1 h before delivery. * Surgery within the first week of life, * major congenital malformations, * chromosomal syndromes, * inherited metabolic disorders, * fetal hydrops

Outcomes

Primary Outcomes

Survival without major morbidities.

Survival without IVH \>/=3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS.

Time frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks

Secondary Outcomes

Individual components of the composite primary outcome will be regarded as secondary outcomes.

Occurrence of IVH \>/=3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS.