Active clinical trials for "Neonatal Sepsis"

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 purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.

Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is not related to their delivery but to the hospital environment. Preventing these infections results in shorter hospital stays for babies, less risk of long term health problems and less health care resources required to care for them. Hand washing alone doesn't remove all bacteria from the hands of healthcare workers, and studies have shown that infections in adults and children admitted to hospital decrease if health care providers use clean, non- sterile gloves when treating patients. The main focus of this study will be to find out if using gloves when caring for newborns in the NICU is better than washing hands alone. McMaster Children's Hospital and The Hospital for Sick Children will be the pilot sites to participate in a future larger study where some infants will be cared for using non-sterile gloves, and others will be cared for using the standard hand washing method.

The purpose of the study is to evaluate the role of antibiotics in preventing infection in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation. It is believed that these babies are more prone to infections as meconium enhances bacterial growth and may predispose such babies to secondary bacterial infections. In addition, meconium passage has been incriminated as a pointer of in-utero infection. Whether use of antibiotics in babies born through meconium stained amniotic fluid will reduce the infectious episodes and complications thereof or not is not clear. Moreover, there is not much published literature to prove or refute the same. Most clinicians have a low threshold for using antibiotics in such babies. In view of the uncertainty regarding antibiotic usage in these babies, the investigators decided to investigate the role of prophylactic antibiotics in prevention of neonatal sepsis in babies born through meconium stained amniotic fluid.

Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.

Introduction and objectives: Lipid emulsions play an important role in parenteral nutrition in preterm infants. We aim to evaluate the effect of two different intravenous lipid emulsions on the outcomes of neonatal sepsis in preterm infants. Methods: A randomized controlled trial is conducted in the Neonatal Care Unit of Mansoura University Children's Hospital, Egypt. Forty preterm infants with clinically suspected sepsis are enrolled and assigned randomly into one of two groups, one receive MOFS lipid emulsion (MOFS group) and the other receive pure soyabean oil-based emulsion (S group). Clinical and epidemiological data are collected. Assessment is done on 1st day and 7th day post randomization including growth parameters, complete blood count, C-reactive protein, random blood glucose, serum creatinine, serum triglyceride, soluble intercellular adhesion molecule 1 (sICAM-1) and leukocyte integrin β2. Between-groups and within-group differences will be analyzed statistically.

Assess the efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a marker of oxidative stress and by comparing other clinical and laboratory parameters of sepsis in both groups.

The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional Birth Attendant will provide care to the mothers and newborns at household level. A Basic Health Unit will take care of non complicated referrals and provide injectable antibiotics for neonatal sepsis. Complicated (definitions given in methods section) cases will be referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of Health, Sindh and the Federal Ministry of Health are study collaborators, therefore, guaranteeing scaling up of interventions at national level. Hypothesis: In comparison to a basic package of existing training program of LHWs, enhanced training of LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn infections and LBW (combined with prompt referral) will result in an additional 30% reduction in neonatal mortality.

Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 & 5. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas. Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality. Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used. Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in the intervention areas.

The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates. The study was also intended to investigate reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders. Probotic bacteria contained in the investigational product administered directly after birth are beneficial for the development of normal gut microflora and can prevent or significantly limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic flora in a hospital setting. Permanent colonisation with commensal flora in very early life improves gastrointestinal function in premature neonates by reducing the onset of or by decreasing the severity of the signs and symptoms of feeding intolerance and generalised bacterial infections, including sepsis and necrotizing enterocolitis.