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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic prophylaxis for EOS | Active Comparator |
| |
| Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS | Procedure | Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Risk factors for EOS:
Surgery within the first week of life,
major congenital malformations,
chromosomal syndromes,
inherited metabolic disorders,
fetal hydrops
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Dani | Contact | 0039 055 7948421 | carlo.dani@unifi.it |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000077740 | Procalcitonin |
| D019072 | Antibiotic Prophylaxis |
| ID | Term |
|---|---|
| D002116 | Calcitonin |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Antibiotic prophylaxis for EOS | Procedure | Infants will receive antibiotic prophylaxis for EOS. |
|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D011506 | Proteins |
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |