Prevention of Nosocomial Bacteremia Among Zambian Neonates

Not Applicable

Completed

• Conditions: Neonatal Mortality; Neonatal Sepsis
• Interventions: Drug: Chlorhexidine gluconate (CHG); Behavioral: Hand hygiene (HH); Behavioral: Infection control training; Other: Infection control reminders via SMS text

• Registration Number: NCT02386592
• Lead Sponsor: Boston University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-12
• Study Start: 2015-09-01
• Primary Completion: 2017-04-15
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Hand hygiene (HH)	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
Intervention	Chlorhexidine gluconate (CHG)	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
Intervention	Infection control training	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
Intervention	Infection control reminders via SMS text	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

Primary Outcome Measures

Name	Time	Method
All-cause neonatal mortality in hospitalized neonates	18 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia