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

NCT01290003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-09-29

No results posted yet for this study

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.

Conditions

  • Neonatal Sepsis

Interventions

DRUG

Piperacillin-Tazobactam and Amikacin

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)

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Sushma Nangia, MBBS, MD, DM · Lady Hardinge Medical College, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
2 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290003 on ClinicalTrials.gov