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

University of Florence (UNIFI)

Status: Not yet enrolling

Conditions: Early-Onset Neonatal Sepsis

Treatments: Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS; Procedure: Antibiotic prophylaxis for EOS

Study type: Interventional

Funder types: Other

Identifiers

NCT05796115

PROPOSE02

Details and patient eligibility

About

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).

Enrollment: 266 estimated patients

Sex: All

Ages: Under 3 hours old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 2 patient groups

Antibiotic prophylaxis for EOS

Active Comparator group

Treatment:

Procedure: Antibiotic prophylaxis for EOS

Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

Experimental group

Treatment:

Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS