Active clinical trials for "Neonatal Sepsis"

This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T ratio), and blood culture along with CRP and IL-6 levels. A cohort (63 subjects) of preterm infants will be recruited. All the participants will be evaluated for sepsis using placental/umbilical cord blood (PUCB) and subject blood sample during the first 12 hours of life (after birth).

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 aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. And to evaluate the effect of bovine colostrum concentrate on feeding tolerance, growth, hospital stay and mortality in preterm neonates.

Background: Neonatal sepsis is a major contributor to global under five mortality. In developing countries a major proportion of neonatal sepsis is thought to emanate from the healthcare setting, due to challenges in infection prevention practices. Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal infection control interventions on the incidence of neonatal sepsis; and colonization by multidrug resistant Gram negative bacteria (MDRGNB). Methods: A controlled before and after interventional trial comprising a 7 month pre- intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission. This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected from a subpopulation of included neonates at intervention site (KBTH) and control site (37 Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs will be collected from surfaces at the NICU to assess MDRGNB contamination of the environment. The intervention comprises infection prevention strategies including implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence of neonatal sepsis. Expected Outcome: This study will contribute to improved infection prevention practices in the participating NICUs and highlight lessons which other national and regional NICUs may learn from.

The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.

The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.

The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis

124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP, procalcitonin (PCT), and tumor necrosis factor-α (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis manifestations but had negative BC and No EOS included neonates free of evident clinical sepsis manifestations, had negative BC and showed no deterioration till 72-hr after admission.

Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments). Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be linked to other neonatal conditions, such as prematurity and birth defects are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. Excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality. The primary objective is to identify, on a cohort of 250 patients, the optimal biomarker combination with good diagnostic performance (i.e. with maximal Area Under the ROC Curve) to early exclude a LOS diagnostic in newborns of at least 7 days of life with suggestive signs. This identification will be carried out, as a secondary objective, with a sub-group of pre-term neonates whose birth weight is less than 1500 grams. The diagnostic value of the clinical signs that are suggestive of LOS will also be determined (sensitivity, specificity, negative and positive predictive values). Once identified, the biomarker combination is expected to reduce unjustified antibiotic use.

The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties. If successful, the use of lactoferrin as a protective protein could profoundly affect clinical care of neonates both in the developed and developing world.