Prevention of Nosocomial Bacteremia Among Zambian Neonates

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 9410
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia, 10101
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Intervention; 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); 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.; Other Names: 2% chlohexidine gluconate body wash; Behavioral: Hand hygiene (HH); 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.; Behavioral: Infection control training; 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.; Other: Infection control reminders via SMS text; Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Children's Hospital of Philadelphia; University Teaching Hospital, Lusaka, Zambia; Zambia Center for Applied Health Research and Development
• Investigators: Principal Investigator: Davidson H Hamer, MD, BU School of Medicine

Publications and helpful links

General Publications

• Gill CJ, Mantaring JB, Macleod WB, Mendoza M, Mendoza S, Huskins WC, Goldmann DA, Hamer DH. Impact of enhanced infection control at 2 neonatal intensive care units in the Philippines. Clin Infect Dis. 2009 Jan 1;48(1):13-21. doi: 10.1086/594120.
• Aiken AM, Mturi N, Njuguna P, Mohammed S, Berkley JA, Mwangi I, Mwarumba S, Kitsao BS, Lowe BS, Morpeth SC, Hall AJ, Khandawalla I, Scott JAG; Kilifi Bacteraemia Surveillance Group. Risk and causes of paediatric hospital-acquired bacteraemia in Kilifi District Hospital, Kenya: a prospective cohort study. Lancet. 2011 Dec 10;378(9808):2021-2027. doi: 10.1016/S0140-6736(11)61622-X. Epub 2011 Nov 29.
• Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.
• Mwananyanda L, Pierre C, Mwansa J, Cowden C, Localio AR, Kapasa ML, Machona S, Musyani CL, Chilufya MM, Munanjala G, Lyondo A, Bates MA, Coffin SE, Hamer DH. Preventing Bloodstream Infections and Death in Zambian Neonates: Impact of a Low-cost Infection Control Bundle. Clin Infect Dis. 2019 Sep 27;69(8):1360-1367. doi: 10.1093/cid/ciy1114.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): April 15, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (ESTIMATE): March 12, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Neonatal Sepsis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: H-33473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are willing to share participant and microbiological data after publication of the main study findings and after receipt of an acceptable analysis plan.
• IPD Sharing Time Frame: 12 months after publication of the main study findings and full microbiological analysis
• IPD Sharing Access Criteria: Upon receipt and review of an acceptable proposal for analysis of the data, we will share the database.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No