PROPOSE: PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

Sponsor

University of Florence (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05796115

Collaborator

(none)

266

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Early-Onset Neonatal Sepsis	Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS Procedure: Antibiotic prophylaxis for EOS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2025

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antibiotic prophylaxis for EOS	Procedure: Antibiotic prophylaxis for EOS Infants will receive antibiotic prophylaxis for EOS.
Experimental: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS	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.

Arm

Intervention/Treatment

Active Comparator: Antibiotic prophylaxis for EOS

Procedure: Antibiotic prophylaxis for EOS

Infants will receive antibiotic prophylaxis for EOS.

Experimental: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

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.

Outcome Measures

Primary Outcome Measures

Survival without major morbidities. [Participants will be monitored for the duration of hospital stay which is an average of 10 weeks]
Survival without IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.

Secondary Outcome Measures

Individual components of the composite primary outcome will be regarded as secondary outcomes. [Participants will be monitored for the duration of hospital stay which is an average of 10 weeks]
Occurrence of IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Hours to 3 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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