PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

NCT05796115 | Unknown

• 1 other identifier: PROPOSE02
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Early-Onset Neonatal Sepsis

Keywords

Early-Onset Sepsis; Procalcitonin; Presepsin; Preterm infant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Antibiotic prophylaxis for EOS

ACTIVE COMPARATOR

Procedure: Antibiotic prophylaxis for EOS

Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

EXPERIMENTAL

Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

Interventions

Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS PROCEDURE

Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life.

Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

Antibiotic prophylaxis for EOS PROCEDURE

Infants will receive antibiotic prophylaxis for EOS.

Antibiotic prophylaxis for EOS

Eligibility Criteria

• Age: 0 Hours - 3 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

MeSH Terms

Conditions

Neonatal Sepsis; Premature Birth

Interventions

Procalcitonin; Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins; Chemoprevention; Drug Therapy; Therapeutics; Premedication

Central Study Contacts

Carlo Dani

CONTACT

0039 055 7948421; carlo.dani@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pediatrics

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 3, 2023

Record last verified: 2023-03