[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-sepsis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-sepsis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,74,99,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100644464","cbc-indices-and-serum-lactate-in-neonatal-sepsis-100644464",false,"NCT07663084","CBC Indices and Serum Lactate in Neonatal Sepsis","Diagnostic and Prognostic Values of CBC Indices and Serum Lactate in Neonatal Sepsis","Inclusion Criteria:\n\n* Neonates aged 0 to 28 days (term and preterm).\n* Presence of two or more clinical signs highly suggestive of sepsis (e.g., temperature instability \\[\\\u003C 36.5°C or \\> 37.5°C\\], tachycardia\u002Fbradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone).\n* Informed written consent obtained from the parents or legal guardians.\n\nExclusion Criteria:\n\n* Neonates with severe congenital anomalies or chromosomal abnormalities.\n* Neonates diagnosed with Inborn Errors of Metabolism (which inherently alter lactate levels).\n* Neonates with severe perinatal asphyxia or Hypoxic-Ischemic Encephalopathy (HIE), as these conditions cause profound primary lactic acidosis independent of sepsis.\n* Neonates who received prior broad-spectrum intravenous antibiotics for more than 24 hours prior to admission.\n* Neonates who have received prior blood transfusions.\n* Neonates requiring immediate surgical intervention.","ALL","0 Days","28 Days",{"count":20,"type":21},80,"ESTIMATED","OBSERVATIONAL","Neonatal sepsis is a leading cause of illness and death in Neonatal Intensive Care Units (NICUs). Diagnosing it quickly is challenging because the early signs often overlap with other common newborn health issues. While a blood culture is the most accurate way to confirm an infection, the results can take 48 to 72 hours. This delay highlights the need for faster, more accessible diagnostic tools.\n\nThis observational study aims to find quicker ways to diagnose neonatal sepsis and predict its severity using readily available blood tests. Researchers are investigating whether specific details from a standard Complete Blood Count (CBC), such as the variation in red blood cell size (RDW), the average size of platelets (MPV), and the ratio of immature to total white blood cells (I\u002FT ratio), combined with serum lactate levels (a marker of tissue oxygenation and stress) can serve as reliable, early warning signs.\n\nThe study will enroll newborns (0 to 28 days old) admitted to the NICU who show clinical signs of a possible infection. Upon admission and before starting any antibiotic treatment, a small blood sample will be drawn to measure these CBC indices and serum lactate, alongside the standard blood culture.\n\nBy comparing these rapid blood test results with the final blood culture outcomes and the infants' overall clinical progress in the NICU, the research team hopes to determine if this simple combination of markers can help doctors diagnose sepsis earlier, anticipate the severity of the illness, and make faster, life-saving treatment decisions.",[25,26],"Neonatal Sepsis","Sepsis",[25,28,29,30,31,32,33,34],"Complete Blood Count Indices","Serum Lactate","Mean Platelet Volume","Immature-to-Total Neutrophil Ratio","Red Cell Distribution Width","Diagnostic Biomarkers","Prognosis","NOT_YET_RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-23","ACTUAL",{"date":41,"type":21},"2026-08",{"date":43,"type":21},"2027-09",{"name":45,"class":46},"Assiut University","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100625337","chlorhexidine-gluconate-and-alcohol-hand-rubbing-on-healthcare-associated-infection-100625337","NCT07421323","Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection","a Comparison Between Effect of Chlorhexidine Gluconate and Alcohol Hand Rubbing on Healthcare-associated Infection","Inclusion Criteria:\n\nNeonates \\\u003C37 weeks gestational age admitted to NICU of Alexandria University Children's Hospitals\n\nExclusion Criteria:\n\n* Patients with any of the following will be excluded:\n\n  1. Obvious major congenital abnormalities, immunodeficiency and inborn error of metabolism.\n  2. Early onset sepsis (before the third day).\n  3. Infants more than 72 hours of age at the time of randomization.\n  4. Parental consent lacking\u002Frefusal.","6 Hours","1 Day",{"count":57,"type":21},100,"INTERVENTIONAL",[60],"NA","This study aims to compare of effect of chlorhexidine gluconate and alcohol hand rubbing on healthcare-associated infection (HCAI) in neonatal intensive care unit at Alexandria University Children Hospital.",[25],"RECRUITING","2026-02-12",{"date":66,"type":39},"2026-02-19",{"date":68,"type":39},"2025-08-01",{"date":70,"type":21},"2026-04-01",{"name":72,"class":46},"Alexandria University",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":58,"phases":82,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":4},"100622186","phase-3-effect-of-n-acetylcysteine-as-adjunct-therapy-on-the-clinical-outcome-of-neonatal-sepsis-100622186","NCT07380347","Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis","Inclusion Criteria:\n\n* Age at admission: Near-term and term (≥ 32 gestational weeks) neonates up to 28 days of life.\n* Neonates diagnosed with sepsis: diagnosis of sepsis based on high probable sepsis (HPS) and probable sepsis (PRS) according to the criteria employed for defining the sepsis score.\n\nExclusion Criteria:\n\n* Critical major congenital anomalies that are incompatible with first 28 days vitality.\n* Hypersensitivity to NAC\n* Parents or guardians who decline consent.",{"count":81,"type":21},50,[83],"PHASE3","Neonatal sepsis (NS) is a life-threatening condition characterized by systemic inflammation in response to infection during the first 28 days of life. Nowadays, it is generally acknowledged that one of the critical pathogenic mechanisms involved in neonatal sepsis is oxidative stress, which plays a critical role in amplifying inflammation and cellular injury. During sepsis, activated immune cells such as neutrophils and macrophages produce large amounts of ROS and RNS as part of the antimicrobial defense. Also, IL-6 and IL-8 are the main cytokines involved in the initiation of the sepsis cascade in the newborn, following that, several oxidative stress-related pathways are activated through different mechanisms, triggering the initiation of a self-maintaining \"sepsis redox cycle\" finally leading to cell oxidative damage and mitochondria dysfunction. One of the major consequences of oxidative stress is lipid peroxidation, in which ROS attack polyunsaturated fatty acids (PUFAs) in cellular membranes which leads to membrane dysfunction and cellular injury. One of the major consequences of oxidative stress is lipid peroxidation, in which ROS attack polyunsaturated fatty acids (PUFAs) in cellular membranes which leads to membrane dysfunction and cellular injury. Elevated levels of MDA in neonatal sepsis are associated with increased oxidative damage and worse clinical outcomes, making it a valuable marker for assessing the oxidative burden in sepsis. N-acetylcysteine (NAC) has the ability to replenish intracellular glutathione levels and neutralize ROS makes it promising as adjunct therapy in neonatal sepsis. administering NAC to neonates with sepsis could potentially improve clinical outcomes by reducing oxidative damage through replenishing glutathione and scavenging free radicals result in reduction of MDA level which is a biomarker for lipid peroxidation and oxidative damage, preserving organ function, and preventing the progression to severe complications like MODS. NAC efficacy in neonatal sepsis is not studied yet, and it is unknown whether NAC is beneficial as adjunct therapy for neonatal sepsis or not.\n\nThe aim of this study is to evaluate the efficacy of N-acetylcysteine as an adjunctive therapy in neonatal sepsis by assessing clinical improvement using the sepsis score and nSOFA score, reduction of oxidative stress through changes in malondialdehyde (MDA) levels, and its impact on the length of hospital stay and mortality.",[25],[87,25,88,89,90],"NAC","MDA","Sepsis Score","nSOFA","2026-01-24",{"date":93,"type":39},"2026-02-02",{"date":95,"type":21},"2026-02",{"date":41,"type":21},{"name":98,"class":46},"Ain Shams University",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":16,"minAge":55,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":73},"100564791","role-of-presepsin-as-a-novel-biomarker-in-diagnosis-of-neonatal-sepsis-100564791","NCT06633770","Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis","Inclusion Criteria:\n\n* Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis, e.g., ( prolonged labor, premature rupture of membrane (PROM), maternal intrapartum fever and chorioamnionitis,) and neonates with sepsis-related clinical signs: (temperature instability, apnea, need for supplemental oxygen, bradycardia, tachycardia, hypotension, hypoperfusion, feeding intolerance, and abdominal distension).\n\nExclusion Criteria:\n\n* Administration of antibiotic therapy prior to admission, Birth asphyxia Laboratory finding suggestive of inborn error of metabolism Congenital anomalies including congenital heart disease",true,"1 Month",{"count":57,"type":21},"-Introduction: Sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection. it is life-threatening entity causing millions of deaths worldwide, with variable clinical manifestations and poses difficulty in diagnosis and treatment. Early recognition of sepsis not only helps in the optimization of treatment but also improves the overall outcome.\n\nNeonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria , viruses, fungi ,or parasites or the toxic products of these., It is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges .The proof of infection is seldom encountered in practice, as the confirmatory microbial culture yield can be as low as 25-30%. Hence, clinicians often depend on commonly available biomarkers such as C-reactive Protein (CRP) and procalcitonin (PCT) for diagnosing infection. Even though helpful, these markers are fraught with errors and limitations There is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions The role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry.\n\nCD14 is a co-receptor present on the surface of the monocyte\u002Fmacrophage. It is a member of the Toll-like receptors (TLRs),with an ability to identify groups of ligands of both gram-positive and gram-negative pathogens CD14 exists in two forms namely membrane-bound (mCD14) and a soluble form (sCD14). The sCD14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin D . The N terminal fragment of the sCD14-ST subtype is called presepsin.",[25],"2024-10-07",{"date":112,"type":39},"2024-10-09",{"date":114,"type":21},"2024-12-01",{"date":116,"type":21},"2028-01-30",{"name":118,"class":46},"Sohag University",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":126,"targetDuration":4,"studyType":58,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":73},"100539604","phase-2-intravenous-methylene-blue-for-treating-refractory-neonatal-septic-shock-100539604","NCT06306001","Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock","Intravenous Methylene Blue for Treating Fluid-refractory, Catecholamine-resistant, Neonatal Septic Shock: a Randomized, Placebo-controlled, Superiority Trial","Screening Criteria: preterm infants (\\\u003C37 weeks, \\\u003C28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following\n\n1. Definite\u002Fprobable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein \\>10 mg\u002FdL; (b) procalcitonin as per age-appropriate cut-off (c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d) chest X-ray adjudged as pneumonia by two independent Neonatologists.\n2. Shock: adapted from the definition given by Davis et al 2017\n\n   1. Either SBP \\\u003C age and gestation appropriate cut-off OR\n   2. Presence of any 2 of the following 6 parameters i. HR \\>205\u002Fmin ii. Central pulses either week OR bounding iii. CRT \\>3 sec OR flash refill (\\\u003C1 sec) iv. skin mottled\u002Fcool OR flushed v. urine output \\\u003C0.5 ml\u002Fkg\u002Fh in the preceding 6 hours vi. DBP \\\u003C age and gestation appropriate cut-off\n3. Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml\u002Fkg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg\u002Fkg\u002Fmin) or epinephrine (maximum dose 0.4 µg\u002Fkg\u002Fmin) or norepinephrine (maximum dose 0.4 µg\u002Fkg\u002Fmin).\n\nExclusion Criteria:\n\nexcluded if ≥1 criterion positive:\n\n1. G6PD deficient or family history of G6PD deficiency\n2. Potentially lethal malformation\n3. Congenital heart disease\n4. Severe acute kidney injury\n5. Family history of allergy to methylene blue or food dyes",{"count":127,"type":21},130,[129,83],"PHASE2","Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:\n\n1. Whether MB treatment reduces death to any cause as compared to no MB treatment.\n2. Whether treatment with MB reduces the time to achieve normal blood pressure\n3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.\n4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.",[25,132],"Shock, Septic",[134,135,136,137],"Methylene blue","Neonate","Septic shock","Clinical trial","2024-03-05",{"date":140,"type":39},"2024-03-12",{"date":142,"type":21},"2024-03-15",{"date":144,"type":21},"2027-02",{"name":146,"class":46},"Post Graduate Institute of Medical Education and Research, Chandigarh"]