Neonatal Sepsis at Neonatal Intensive Care Units of Two Major Referral Hospitals in Ghana
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5,433
- Locations
- 1
- Primary Endpoint
- Incidence of neonatal sepsis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Minute to 48 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Admission NICU
- •Birth weight ≥750 Grams
- •≤48 hours of age at time of enrolment
- •Consent to participate obtained from legal guardian
Exclusion Criteria
- •Neonates with severe congenital malformations
- •Neonates who have undergone surgical procedure
Outcomes
Primary Outcomes
Incidence of neonatal sepsis
Time Frame: Post-intervention at 7 months
Incidence of neonatal sepsis including clinical cases treated as sepsis and cases of neonatal sepsis with confirmed bloodstream infections per 1000 admissions.
Secondary Outcomes
- Length of admission in days(Post-intervention at 7 months)
- Rate of hand hygiene compliance per opportunity(Post-intervention at 7 months)
- All-cause mortality(Post-intervention at 7 months)
- Rate of MDR Gram negative bacteria colonization among neonates(During intervention at 2 months and post-intervention at 7 months)
Investigators
Stephanie Bjerrum
MD, PHD, postdoc
University of Copenhagen