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Prevention of Nosocomial Bacteremia Among Zambian Neonates

Primary Purpose

Neonatal Sepsis, Neonatal Mortality

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Chlorhexidine gluconate (CHG)
Hand hygiene (HH)
Infection control training
Infection control reminders via SMS text
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Sepsis

Eligibility Criteria

1 Hour - 28 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • University Teaching Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
February 17, 2015
Last Updated
July 27, 2017
Sponsor
Boston University
Collaborators
University Teaching Hospital, Lusaka, Zambia, Zambia Center for Applied Health Research and Development, Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02386592
Brief Title
Prevention of Nosocomial Bacteremia Among Zambian Neonates
Official Title
Prevention of Nosocomial Bacteremia and Mortality Among Neonates at a Tertiary Referral Center in Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
University Teaching Hospital, Lusaka, Zambia, Zambia Center for Applied Health Research and Development, Children's Hospital of Philadelphia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis, Neonatal Mortality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate (CHG)
Other Intervention Name(s)
2% chlohexidine gluconate body wash
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hand hygiene (HH)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Infection control training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Infection control reminders via SMS text
Intervention Description
Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.
Primary Outcome Measure Information:
Title
All-cause neonatal mortality in hospitalized neonates
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Incidence of nosocomial bacteremia in hospitalized neonates
Description
Incidence of nosocomial bacteremia in hospitalized neonates at UTH before and after the introduction of low-cost infection-control interventions.
Time Frame
18 months
Title
Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates
Description
Measure the attributable risk of maternal, neonatal and hospital factors as well as invasive procedures on nosocomial bacteremia among neonates hospitalizedat UTH
Time Frame
18 months
Title
Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates
Description
Prevalence of nosocomial bacteremia caused by MDR-GNR infections among neonates at UTH.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davidson H Hamer, MD
Organizational Affiliation
BU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Teaching Hospital
City
Lusaka
ZIP/Postal Code
10101
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
19025496
Citation
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.
Results Reference
background
PubMed Identifier
22133536
Citation
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.
Results Reference
background
PubMed Identifier
23363666
Citation
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.
Results Reference
background
PubMed Identifier
30596901
Citation
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.
Results Reference
derived

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Prevention of Nosocomial Bacteremia Among Zambian Neonates

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