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Completed

NCT Number: NCT02386592

Prevention of Nosocomial Bacteremia Among Zambian Neonates

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.

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Mortality Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Teaching Hospital

Lusaka, 10101, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate (CHG)

Drug

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

Hand hygiene (HH)

Behavioral

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.

Infection control training

Behavioral

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.

Infection control reminders via SMS text

Other

Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.

Primary outcomes

  1. All-cause neonatal mortality in hospitalized neonates

    Time frame: 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 outcomes

  1. Incidence of nosocomial bacteremia in hospitalized neonates

    Time frame: 18 months

    Incidence of nosocomial bacteremia in hospitalized neonates at UTH before and after the introduction of low-cost infection-control interventions.

  2. Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates

    Time frame: 18 months

    Measure the attributable risk of maternal, neonatal and hospital factors as well as invasive procedures on nosocomial bacteremia among neonates hospitalizedat UTH

  3. Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates

    Time frame: 18 months

    Prevalence of nosocomial bacteremia caused by MDR-GNR infections among neonates at UTH.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • University Teaching Hospital, Lusaka, Zambia
  • Zambia Center for Applied Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2015
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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