Neonatal Sepsis, Neonatal Mortality
Conditions
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.
Interventions
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.
BEHAVIORALHand 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.
BEHAVIORALInfection 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.
OTHERInfection control reminders via SMS text
Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.
Sponsors
University Teaching Hospital, Lusaka, Zambia
Zambia Center for Applied Health Research and Development
Children's Hospital of Philadelphia
Boston University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Zambia
Outcome results
None listed