PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 266
- 主要终点
- Survival without major morbidities.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Hours 至 3 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.
排除标准
- •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
结局指标
主要结局
Survival without major morbidities.
时间窗: 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.
次要结局
- 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)
研究者
Carlo Dani
Full Professor of Pediatrics
University of Florence