Prevention of Nosocomial Bacteremia Among Zambian Neonates

Study Overview
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Brief Summary
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The purpose of this study is to estimate the burden of disease, identify risk factors associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the investigators propose to study the impact of a novel package of infection control interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center in sub-Saharan Africa.

Detailed Description
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The study is an18 month prospective quasi-experimental evaluation of nosocomial bacteremia and mortality among hospitalized neonates and will consist of a 6-month baseline period to capture the incidence and all-cause mortality of nosocomial BSIs, a 1-month implementation period of low-cost infection control strategies (including alcohol-based hand rub [AHR], 2% chlorhexidine gluconate [CHG], hospital staff education and text message-based reminders of infection control recommendation) and an 11-month intervention period. All neonates admitted to the neonatal intensive care unit (NICU) of the University Teaching Hospital (UTH) in Lusaka, Zambia during the study period will be eligible for study enrollment. This study will determine the capacity of an innovative bundle of low cost, simple and locally available interventions that leverage new technologies and expand application of highly effective interventions in order to reduce the incidence of nosocomial bacteremia among NICU patients in a developing country setting.

Official Title
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Prevention of Nosocomial Bacteremia and Mortality Among Neonates at a Tertiary Referral Center in Zambia

Conditions
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Neonatal Sepsis, Neonatal Mortality

Intervention / Treatment
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* Drug: Chlorhexidine gluconate (CHG)
* Behavioral: Hand hygiene (HH)
* Behavioral: Infection control training
* Other: Infection control reminders via SMS text


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates admitted to the study site NICU during the study period (including both inborn and outborn neonates) Exclusion Criteria: Neonates without documented birth date Parent or guardian unavailable or unwilling to provide consent

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Infection control package consisting of alcohol hand rub hand hygiene (HH), 2% chlorhexidine gluconate (CHG) body washes, infection control training, and text messages with basic Infection control reminders via SMS text | Drug: Chlorhexidine gluconate (CHG)<br>* All enrolled neonates admitted to the NICU during the implementation and intervention periods will undergo CHG bathing (sparing head and face) at the time of admission at and thereafter once weekly.<br>* Other names: 2% chlohexidine gluconate body wash;Behavioral: Hand hygiene (HH)<br>* Alcohol hand rub will be produced in the hospital pharmacy and will be readily available in the NICU (via wall-mounted dispensers) throughout the intervention period. Hand hygiene among NICU physicians and nurses will actively be promoted through the intervention period.<br>Behavioral: Infection control training<br>* All NICU healthcare workers will receive infection prevention training which will involve structure training on HH, universal precautions, neonatal skin antisepsis and peripheral IV placement and line care.<br>Other: Infection control reminders via SMS text<br>* Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause neonatal mortality in hospitalized neonates | in hospitalized neonates at University Teaching Hospital (UTH), a large tertiary referral center, in Zambia before and after the introduction of low-cost infection-control interventions. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nosocomial bacteremia in hospitalized neonates | Incidence of nosocomial bacteremia in hospitalized neonates at UTH before and after the introduction of low-cost infection-control interventions. | 18 months | 
| Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates | Measure the attributable risk of maternal, neonatal and hospital factors as well as invasive procedures on nosocomial bacteremia among neonates hospitalizedat UTH | 18 months | 
| Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates | Prevalence of nosocomial bacteremia caused by MDR-GNR infections among neonates at UTH. | 18 months |