Neonatal Sepsis at Neonatal Intensive Care Units in Ghana
Condition: Neonatal SEPSIS
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional

Summary: 
      Background: Neonatal sepsis is a major contributor to global under five mortality. In
      developing countries a major proportion of neonatal sepsis is thought to emanate from the
      healthcare setting, due to challenges in infection prevention practices.

      Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal
      infection control interventions on the incidence of neonatal sepsis; and colonization by
      multidrug resistant Gram negative bacteria (MDRGNB).

      Methods: A controlled before and after interventional trial comprising a 7 month pre-
      intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates
      admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will
      be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission.
      This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected
      from a subpopulation of included neonates at intervention site (KBTH) and control site (37
      Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs
      will be collected from surfaces at the NICU to assess MDRGNB contamination of the
      environment. The intervention comprises infection prevention strategies including
      implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence
      of neonatal sepsis.

      Expected Outcome: This study will contribute to improved infection prevention practices in
      the participating NICUs and highlight lessons which other national and regional NICUs may
      learn from.
    

Detailed description: 
      Background In 2012, it was estimated that approximately 680,000 neonatal deaths in developing
      countries were due to bacterial infections, with an incidence risk of 7.6% and a case
      fatality risk of 9.8. A major proportion of neonatal infections are expected to be
      health-care associated, due to inadequate infrastructure and resources for infection control
      and prevention. Hospital acquired infections(HAIs) are associated with multi-drug resistant
      (MDR) bacteria, which increases the risk of therapeutic failure due to the limited choice of
      available antibiotics. HAIs also lead to extended duration of admission, increased medical
      costs, morbidity and mortality.

      Transmission of MDR bacteria in the hospital environment is thought to be due to unhygienic
      practices which occur during clinical invasive procedures, (e.g. artificial ventilation,
      catheter and intravenous line insertion). Neonatal infections may also be due to invasion by
      colonizing bacteria of the neonate, usually originating from maternal and environmental
      flora.

      According to the WHO, 50% of HAIs are preventable through implementation of infection control
      practices. The WHO has instituted a multimodal hand hygiene strategy that has been found to
      improve hand hygiene compliance and reduce the prevalence of HAIs. However, the effectiveness
      of this strategy in a neonatal intensive care unit (NICU) with high risk of colonization with
      environmental bacteria has not been studied. In fact, most studies that have examined the
      potential sources and mode of transmission of organisms that cause neonatal sepsis have been
      conducted in well-resourced countries.

      The hypothesis of the study is that the hospital environment serves as a source of MDR Gram
      negative bacteria responsible for neonatal colonization and sepsis among patients admitted at
      the NICU of the KBTH; and that implementation of the multimodal hand hygiene strategy will
      lead to a reduction in the incidence of neonatal sepsis and colonization by MDR Gram negative
      bacteria.

      Objective To determine the impact of multi-modal infection control interventions on the
      incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.

      Method This study will evaluate the impact of WHO multimodal hand hygiene strategy on the
      incidence of neonatal sepsis and neonatal colonization by MDR Gram negative bacteria as well
      as pilot surveillance of neonatal sepsis at the participating sites.

      Study setting: Data will be collected at the NICU of the KBTH and the 37 Military Hospital,
      Accra, Ghana.

      Study Design: The study will be a controlled before and after interventional trial with one
      interventional site (KBTH) and a control site (37 Military hospital). Data will be collected
      over 19 months with a baseline phase of 7 months; an interventional phase of 5 months; and a
      post intervention phase of 7 months.

      Intervention: The WHO multimodal hand hygiene strategy comprises five essential elements;
      system change-availability of alcohol-based hand rub at the point of care and/ or access to
      safe continuous water supply and soap and towels; training and education of healthcare
      professionals; monitoring of hand hygiene practices and performance feedback; reminders in
      the workplace; and the creation of a handhygiene safety culture with the participation of
      both individual healthcare workers and senior hospital managers.
    

Intervention name(s): The WHO multimodal hand hygiene strategy
Intervention type(s): Combination Product
Intervention description(s): Comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.
Other intervention name(s): Hand hygiene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled before and after interventional trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neonatal sepsis; Infection control; Hand hygiene; WHO multi modal