Implementing the Comprehensive Unit-based Safety Program to Reduce Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

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Clinical Sites: 

This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. Dr. Aaron Milstone is the PI, and Dr. Amita Gupta and Yuka Manabe are Co-PIs. The Study Investigator is Dr. Julia Johnson, and Dr. Bharat Randive is the Study Coordinator.

Of the 2.8 million babies dying within the first 4 weeks of life every year, 23% are estimated to die due to infection, including sepsis and pneumonia. While childhood mortality has been reduced significantly throughout the world, progress has been much slower in reducing neonatal mortality. In regions with the highest mortality for neonates, infection accounts for 30-50% of deaths. These trends hold true in India, where substantial gains have been made in improving survival of children, but the neonatal mortality rate continues to be unacceptably high at 30.9 per 1,000 live births as of 2012. In India, 55% of under-five deaths occur within the first month of life, and over 30% of these deaths are due to infectious causes.2 More than a quarter of neonatal deaths worldwide occur in India alone.

Facility-based births are increasing and the number of Neonatal Intensive Care Units (NICUs) is growing to accommodate neonates requiring more intensive care, including premature neonates and infants with sepsis. A 2005 systematic review by Zaidi and colleagues described available data on burden of neonatal HAIs in low resource settings. Included studies reported a wide range of neonatal HAI: 6.5 to 38 per 1,000 live births. Gram negatives predominated, and Klebsiella pneumoniae was the most common pathogen. Approximately 70% of isolated pathogens would not be susceptible to the most commonly used empiric regimen, ampicillin and gentamicin. A recently published prospective cohort study conducted at four Indian tertiary care hospitals in Delhi enrolled over 13,000 inborn neonates and followed them prospectively, with a reported incidence of clinical sepsis of 14.3% and culture-confirmed sepsis of 6.2%. Similar to previously published Indian studies, Gram negative pathogens caused the majority of cases, and antibiotic resistance was ubiquitous, with 82% of Acinetobacter spp. and 54% of Klebsiella spp. meeting criteria for multidrug resistance.

Primary Objectives:

  1. To reduce the incidence of late-onset culture-confirmed bloodstream infection in neonates admitted to the NICU by promoting adherence with evidence-based guidelines through use of CUSP

  2. To improve local safety culture in the NICU through implementation of CUSP

Secondary Objective:

To reduce mortality after the first 3 days of life in neonates admitted to the NICU.

  • Bharati Vidyapeeth University Medical College
  • KEM Hospital