Neonatal Sepsis Clinical Trial
Official title:
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05692128 -
Frequency and Severity of Thrombocytopenia in Neonatal Sepsis
|
||
Completed |
NCT00942084 -
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
|
Phase 1 | |
Completed |
NCT06002295 -
A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns
|
Phase 2 | |
Not yet recruiting |
NCT05114057 -
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
|
N/A | |
Recruiting |
NCT04528251 -
Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes
|
||
Active, not recruiting |
NCT03871491 -
Azithromycin-Prevention in Labor Use Study (A-PLUS)
|
Phase 3 | |
Completed |
NCT03746743 -
Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II
|
||
Not yet recruiting |
NCT06113653 -
Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis
|
||
Completed |
NCT03199547 -
Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death
|
Phase 3 | |
Completed |
NCT02147327 -
Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities
|
N/A | |
Completed |
NCT01005589 -
CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis
|
N/A | |
Completed |
NCT00866567 -
Defects in Opsonophagocytosis in Premature Infants
|
N/A | |
Completed |
NCT02281890 -
Neurodevelopmental Outcomes After Suspected or Proven Sepsis: Secondary Analysis of INIS Trial Database
|
N/A | |
Suspended |
NCT05156333 -
Probiotics and GBS Colonization in Pregnancy
|
N/A | |
Recruiting |
NCT05127070 -
Evaluating the NeoTree in Malawi and Zimbabwe
|
||
Completed |
NCT03755635 -
Neonatal Sepsis at Neonatal Intensive Care Units in Ghana
|
N/A | |
Completed |
NCT03247920 -
Reduction of Intravenous Antibiotics In Neonates
|
Phase 4 | |
Completed |
NCT03295162 -
Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis
|
Phase 1/Phase 2 | |
Completed |
NCT02954926 -
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
|
Phase 3 | |
Withdrawn |
NCT01723501 -
Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth
|
Phase 2/Phase 3 |