View clinical trials related to Neonatal Sepsis.
Filter by:The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.
Oral lactoferrin versus Placebo will be given to preterm neonates
Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.
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.
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery
Although advances in neonatal care have improved survival and reduced complications in preterm infants, sepsis still contributes significantly to mortality and in Neonatal Intensive Care Units (NICUs), in particular for very-low-birth-weight (VLBW, <1500 g) and extremely-low-birth-weight (ELBW, <1000g). Based on the timing of the infection neonatal sepsis has been classified into early-onset sepsis (EOS) and late-onset sepsis (LOS), with differences in the mode of transmission and predominant organisms. EOS is defined as onset in the first 3 days of life generally due to vertical transmission of bacteria from mothers to infants during the intrapartum period. LOS occurs after 3 days of life and it is attributed to pathogens acquired postnatally (horizontal transmission). Considering generally neonatal sepsis in Europe, 90% of the responsible bacteria resulted to be: Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, e Listeria monocytogenes. The diagnosis is difficult because clinical signs, particularly early in the course of disease, are subtle and nonspecific, and laboratory tests and blood culture are not always reliable. Moreover. blood culture (considered the 'gold standard) takes 48-72 hours for result. In fact the cultural method requires the presence of living and vital germs, depends on the volume of the sample - serious problem in neonatal population -, several hours are needed to process the sample, possibly resulting falsely negative in subjects undergoing concomitant antibiotic treatment or a false positive result can be found by contamination. The method based on molecular biology does not require living germs and, therefore, is not characterised by the sensitivity limitations. Such method can result to be extremely effective in patients receiving antibiotic therapy. In the present study, when an infant has to undergone blood sample for bacteria culture to verify a possible sepsis, a residual blood (200µl) is processed in the same time using a kit based on molecular biology. This kit is designed to obtain the highest sensitivity and specificity in the determination of most invasive bacterial diseases (meningitis, sepsis, pneumonia, etc.) affecting full-term, preterm infants to determine any presence of bacterial DNA belonging to all serotypes of Klebsiella pneumoniae, Escherichia coli, Streptococcus agalactiae and Listeria monocytogenes. The target bacteria have been chosen on the basis of the current Italian epidemiological context, so as to include germs causing about 90% of the meningitis/sepsis cases among the neonatal population. The detection system can unmistakably identify the germ against which it is directed and without causing any cross-reaction with other germs or human DNA.. The results obtained with this method have demonstrated a 100% specificity (no false positive result) The sensitivity of this method compared with the cultural method has turned out to be twice as high. The aim of the present study is to compare the efficacy of the blood culture method and the kit for molecular detection of bacterial DNA (all serotypes of Klebsiella pneumoniae, Escherichia coli, Streptococcus agalactiae and Listeria monocytogenes) considering the relevant epidemiology of our NICU, in order to verify the relative frequency of sepsis (EOS and LOS) caused by the target bacteria on the whole frequency of the bacteria responsible of all the sepsis in our ward.
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development. In the first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given supplemental parenteral nutrition (PN). A fast transition to full EN is important to improve gut maturation and reduce the high risk of late-onset sepsis (LOS), related to their immature immunity in gut and blood. Conversely, too fast increase of EN predisposes to feeding intolerance and necrotizing enterocolitis (NEC). Further, human milk feeding is not sufficient to support nutrient requirements for growth of very preterm infants. Thus, it remains a difficult task to optimize EN transition, achieve adequate nutrient intake and growth, and minimize NEC and LOS in the postnatal period of very preterm infants. Mother´s own milk (MM) is considered the best source of EN for very preterm infants and pasteurized human donor milk (DM) is the second choice if MM is absent or not sufficient. The recommended protein intake is 4-4.5 g/kg/d for very low birth infants when the target is a postnatal growth similar to intrauterine growth rates. This amount of protein cannot be met by feeding only MM or DM. Thus, it is common practice to enrich human milk with human milk fortifiers (HMFs, based on ingredients used in infant formulas) to increase growth, bone mineralization and neurodevelopment, starting from 7-14 d after birth and 80-160 ml/kg feeding volume per day. Bovine colostrum (BC) is the first milk from cows after parturition and is rich in protein (80-150 g/L) and bioactive components. These components may improve gut maturation, NEC protection, and nutrient assimilation, even across species. Studies in preterm pigs show that feeding BC alone, or DM fortified with BC, improves growth, gut maturation, and NEC resistance during the first 1-2 weeks, relative to DM, or DM fortified with conventional HMFs. On this background, the investigators hypothesize that BC, used as a fortifier for MM or DM, can reduce feeding intolerance than conventional fortifiers.
The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.
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.