PROCEDURE
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.
PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
Status
Unknown
Phase
Not applicable
Enrollment
266
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
PROCEDURE
Antibiotic prophylaxis for EOS
Infants will receive antibiotic prophylaxis for EOS.
Timeline
From registration to results.
First posted
Apr 3, 2023
Study start
Apr 1, 2023
Primary completion
Mar 31, 2025
Study completion
Sep 30, 2025
Results posted
Not reported
Registry updated
Apr 3, 2023
Outcomes
What the study measures.
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.
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 0 Hours
- Maximum age
- 3 Hours
- Sex
- ALL
- 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
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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