PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
NCT ID: NCT05796115
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
266 participants
INTERVENTIONAL
2023-04-01
2025-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Antibiotic prophylaxis for EOS
Antibiotic prophylaxis for EOS
Infants will receive antibiotic prophylaxis for EOS.
Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
0 Hours
3 Hours
ALL
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Carlo Dani
Full Professor of Pediatrics
Central Contacts
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Other Identifiers
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PROPOSE02
Identifier Type: -
Identifier Source: org_study_id
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