PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

Study Overview
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Brief Summary
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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).

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

Conditions
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Early-Onset Neonatal Sepsis

Intervention / Treatment
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* Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
* Procedure: Antibiotic prophylaxis for EOS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 3 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic prophylaxis for EOS<br> | Procedure: Antibiotic prophylaxis for EOS<br>* Infants will receive antibiotic prophylaxis for EOS.<br>|
| Experimental: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS<br> | Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS<br>* Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early-Onset Sepsis, Procalcitonin, Presepsin, Preterm infant