Prevention of Nosocomial Bacteremia Among Zambian Neonates

Boston University

Status: Completed

Conditions: Neonatal Mortality; Neonatal Sepsis

Treatments: Behavioral: Infection control training; Behavioral: Hand hygiene (HH); Other: Infection control reminders via SMS text; Drug: Chlorhexidine gluconate (CHG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02386592

H-33473

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9,410 patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9,410 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Infection control training

Behavioral: Hand hygiene (HH)

Drug: Chlorhexidine gluconate (CHG)

Other: Infection control reminders via SMS text