PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

Not Applicable

Not yet recruiting

• Conditions: Early-Onset Neonatal Sepsis
• Interventions: Procedure: Antibiotic prophylaxis for EOS; Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS

• Registration Number: NCT05796115
• Lead Sponsor: University of Florence

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study Start: 2023-04-01
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03
• Primary Completion: 2025-03-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic prophylaxis for EOS	Antibiotic prophylaxis for EOS	-
Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS	Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS	-

Primary Outcome Measures

Name	Time	Method
Survival without major morbidities.	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 Outcome Measures

Name	Time	Method
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	Occurrence of IVH \>/=3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS.