Active clinical trials for "Neonatal Sepsis"

Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies. Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been adequately studied in full-term or premature neonates. HSV is a very serious infection in babies <6 months of age and often results in death or profound mental retardation. HSV leads to profound mental retardation in young infants because the virus attacks the central nervous system. The investigators hypothesize that the currently recommended dose of acyclovir is inadequate to produce adequate blood levels to combat herpes simplex infection. The investigators propose to study acyclovir levels in the blood of babies who are placed on acyclovir to treat a suspected HSV infection. This will allow them to determine the appropriate dose in premature infants. This is an unmet public health need because it is likely that the drug behaves differently in premature infants than it does in term infants and older children. Premature babies have more body water and less body tissue. Their kidneys are more immature and do not function as well as full term infants. Premature neonates are also at the greatest risk from herpes infection because they have poorly functioning immature immune systems. Early and appropriate treatment with acyclovir has resulted in improved outcome in term infants.

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success. Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection. Topical treatment can help to reduce the chances of infection as well as increase the chances of early removal. In this regard methylated spirit and chlorhexidine are found to be effective. Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit in newborns for prevention of omphalitis and neonatal sepsis. Materials and Methods: This randomized control trial was carried out in neonatal unit of Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated spirit was used. Neonates were followed till 10th day of life. Careful examination was done for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.

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 related 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. This explains why 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. A previous study (EMERAUDE) aimed to identify new biomarkers to early exclude the diagnosis of LOS, in order to limit antibiotic overuse. This study including 230 neonates revealed high performances of IL6, IL10, NGAL and combinations of PCT/IL10 and PTX3/NGAL. The main objective of the present study will be to validate the performances of these biomarkers in another cohort. The secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.

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.

Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Sepsis accounts for 50% of deaths among community born (and 20% of mortality among hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial resistance, which is increasingly restricting the therapeutic options for medical care providers. Friendly bacteria called "Probiotics" have been used in multiple infectious and inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in many fruits and vegetables and also in human breast milk. These sugars reach the colon undigested and serve as food for the friendly bacteria. The current study uses a probiotic preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to prevent neonatal infections. Currently no conclusive data are available on the utility of probiotics in such conditions. If successful, such inexpensive preventive therapy can be made available to general public in resource poor countries. Similar preparations can also be used in the western world to prevent similar infectious conditions of the neonatal period, especially in preterm infants where sepsis continues to be a major cause of hospital stay and death.

Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired vertically from the mother and manifests shortly after birth. The objective of this study is to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.

Neonatal sepsis has a high risk of morbidity and mortality. The current WHO and national guidelines recommend antibiotics to which resistance is reported in neonatal populations, although the available data is limited. Research on alternative empirical regimens for neonatal sepsis which are affordable, safe and cost-effective, with a step-down oral option, is needed. AMR is an issue of global public health concern and is one of the WHO's global health priority areas. Understanding the benefits, risks, MIC capacity and PK of fosfomycin will influence global policy on the case management of neonates with sepsis in Kenya and international settings.

In the present study, the investigators aim to evaluate the potential of oral probiotics, containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity and mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as early-onset or late-onset GBS infection.

Randomized controlled open-label non-inferiority trial comparing complete intravenous antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28 days) with probable bacterial infection. Primary outcome: - Bacterial re-infection within 28 days after finishing of antibacterial therapy. Secondary outcome(s): Pharmacokinetic profile of oral amoxicillin/clavulanic acid Quality of life Cost-effectiveness Alterations in gut microbiome Use of molecular techniques for better detection of bacterial pathogens