drugset / Trial / NCT01290003

Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor

NCT01290003

Completed 250 enrolled Lady Hardinge Medical College
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2010-06
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 15 mg/kg Intravenous
Subject Amoxicillin Other / unclassified 50 mg/kg Intravenous

Indications