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

Primary Purpose

Early-Onset Neonatal Sepsis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
Antibiotic prophylaxis for EOS
Sponsored by
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Early-Onset Neonatal Sepsis focused on measuring Early-Onset Sepsis, Procalcitonin, Presepsin, Preterm infant

Eligibility Criteria

0 Hours - 3 Hours (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Antibiotic prophylaxis for EOS

    Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Survival without major morbidities.
    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.
    Occurrence of IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.

    Full Information

    First Posted
    March 8, 2023
    Last Updated
    March 21, 2023
    Sponsor
    University of Florence
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796115
    Brief Title
    PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
    Acronym
    PROPOSE
    Official Title
    PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Florence

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Early-Onset Neonatal Sepsis
    Keywords
    Early-Onset Sepsis, Procalcitonin, Presepsin, Preterm infant

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    266 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotic prophylaxis for EOS
    Arm Type
    Active Comparator
    Arm Title
    Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
    Intervention Description
    Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life.
    Intervention Type
    Procedure
    Intervention Name(s)
    Antibiotic prophylaxis for EOS
    Intervention Description
    Infants will receive antibiotic prophylaxis for EOS.
    Primary Outcome Measure Information:
    Title
    Survival without major morbidities.
    Description
    Survival without IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
    Time Frame
    Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
    Secondary Outcome Measure Information:
    Title
    Individual components of the composite primary outcome will be regarded as secondary outcomes.
    Description
    Occurrence of IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
    Time Frame
    Participants will be monitored for the duration of hospital stay which is an average of 10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Hours
    Maximum Age & Unit of Time
    3 Hours
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carlo Dani
    Phone
    0039 055 7948421
    Email
    carlo.dani@unifi.it

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

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