PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05796115

Acronym

PROPOSE

Enrollment

266

Registered

2023-04-03

Start date

2023-04-01

Completion date

2025-09-30

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Onset Neonatal Sepsis

Keywords

Early-Onset Sepsis, Procalcitonin, Presepsin, Preterm infant

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).

Interventions

PROCEDUREProcalcitonin/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.

PROCEDUREAntibiotic prophylaxis for EOS

Infants will receive antibiotic prophylaxis for EOS.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

0 Hours to 3 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactCarlo Dani

carlo.dani@unifi.it0039 055 7948421

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026