Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor
Condition: Neonatal Sepsis
MeSH terms: Sepsis; Neonatal Sepsis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Piperacillin-Tazobactam and Amikacin
Intervention type(s): Drug
Intervention description(s): Inj Piperacillin-Tazobactam 50 mg/Kg/dose 12 hourly IV X 3 days (6 doses) Inj Amikacin 15 mg/kg/dose 24 hourly IV X 3 days (3 doses)
Intervention MeSH terms: Tazobactam; Piperacillin; Amikacin; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antibacterial agents; Neonate; Meconium stained amniotic fluid; Neonatal sepsis