PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Florence
- Enrollment
- 266
- Primary Endpoint
- Survival without major morbidities.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 0 Hours to 3 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Antibiotic prophylaxis for EOS
Intervention: Antibiotic prophylaxis for EOS (Procedure)
Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
Intervention: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS (Procedure)
Outcomes
Primary Outcomes
Survival without major morbidities.
Time Frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Survival without IVH \>/=3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS.
Secondary Outcomes
- 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)
Investigators
Carlo Dani
Full Professor of Pediatrics
University of Florence