PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

Early-Onset Neonatal Sepsis Clinical Trial

— PROPOSE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05796115
• Other study ID #: PROPOSE02
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2023
• Source: University of Florence
• Contact: Carlo Dani
• Phone: 0039 055 7948421
• Email: carlo.dani[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 266
• Est. completion date: September 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 3 Hours

Eligibility

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

Related Conditions & MeSH terms

• Early-Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis

Intervention

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.
• Antibiotic prophylaxis for EOS
Infants will receive antibiotic prophylaxis for EOS.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without major morbidities.	Survival without IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.	Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Secondary	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.	Participants will be monitored for the duration of hospital stay which is an average of 10 weeks