Role of Prophylactic Antibiotics in Preventing Neonatal Sepsis in Neonates Born Through Meconium Stained Amniotic Fluid - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of sepsis
研究概览
简要总结
The purpose of the study is to evaluate the role of antibiotics in preventing infection in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation. It is believed that these babies are more prone to infections as meconium enhances bacterial growth and may predispose such babies to secondary bacterial infections. In addition, meconium passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics in babies born through meconium stained amniotic fluid will reduce the infectious episodes and complications thereof or not is not clear. Moreover, there is not much published literature to prove or refute the same. Most clinicians have a low threshold for using antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these babies, the investigators decided to investigate the role of prophylactic antibiotics in prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.
详细描述
Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. Intra uterine meconium passage in near term or term fetuses has been associated with feto-maternal stress factors and/or infections, whereas meconium passage in post term pregnancies has been attributed to gastro-intestinal maturity. The meconium staining of amniotic fluid occurs in 12% of all live births per annuum. Aspiration of meconium that occurs during intra uterine life or after delivery with the first few breaths may result in or contribute to respiratory pathology known as meconium aspiration syndrome (MAS) which represents a leading cause of the perinatal morbidity, occurring in 5-20% of all babies born through MSAF.
The routine use of antibiotics in MSAF babies has been advocated for a long time as a part of the conventional treatment. Meconium passage in utero is hypothesized to represent a response to fetal bacterial infection in addition to intrauterine hypoxia. Additionally the rationale for use of antibiotics includes the radiographic similarity of MAS to bacterial pneumonia, in vitro enhancement of bacterial growth in presence of meconium as well as the possibility of meconium induced inhibition of phagocytic activity and respiratory burst response by alveolar macrophages rendering patients with MAS more susceptible to infection. These recommendations however are empirical and the incidence of bacterial infection in neonates born through MSAF as well as in MAS has not been systematically evaluated, to date. With the rising concern about the emergence of resistant strains in neonatal ICUs and the possible side effects of antibiotics (like amino glycosides) including nephrotoxicity and ototoxicity in neonates, a systematically conducted, randomized controlled trial is necessary to assess the utility of antibiotics in the routine management of infants with MSAF and MAS. Hence the purpose of this prospective randomized controlled trial is to compare the clinical course, complications, and infection related outcomes in cases of MSAF and MAS, treated with or without antibiotics therapy
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
- None
入排标准
- 年龄范围
- 30 Minutes 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestation > 37 weeks
- •Meconium staining of amniotic fluid
- •Cephalic presentation
- •Singleton pregnancy
排除标准
- •Major Congenital malformation
- •Refusal of consent
研究组 & 干预措施
Antibiotic Group
Neonates randomized to intervention Group(Antibiotic group)will receive the first line antibiotics (Piperacillin-Tazobactam and Amikacin) as per the unit policy for 72 hours. These neonates will also be monitored by performing sepsis screens and blood culture for development of sepsis.
干预措施: Piperacillin-Tazobactam and Amikacin (Drug)
结局指标
主要结局
Incidence of sepsis
时间窗: First 28 days of life
Incidence of sepsis in first 28 days defined as - 1. SUSPECTED SEPSIS - Sepsis Screen \> 2 parameters positive and/or 2. CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria. Sepsis Screen 1. Total leukocyte count \< 5000/mm3 2. Absolute neutrophil count \< 1800/cu.mm.(Low counts as per Monroe chart for term neonates) 3. Immature/total neutrophil ratio \> 0.2 4. Micro-ESR \> 15mm in 1st hour 5. C Reactive Protein (CRP) \> 1 mg/dl
次要结局
- Mortality;(First 28 days of life)
- Respiratory support;(Till discharge from the hospital)
- Duration of Hospital stay(Till discharge)
- Complications(Till discharge)
研究者
Sushma Nangia, M.D.
Professor Pediatrics
Lady Hardinge Medical College