[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,71,100,123,146,174,202,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643095","protein-biomarkers-and-host-rna-expression-profiles-in-congenital-cytomegalovirus-infection-100643095",false,"NCT07635368","Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection","Inclusion Criteria:\n\n1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program.\n2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period.\n3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling.\n\nExclusion Criteria:\n\n1. DBS samples not approved for research use.\n2. DBS samples with insufficient blood material for RNA expression profiling and\u002For proteomic analyses.\n3. Samples with inadequate analytical quality for molecular or proteomic analyses.",true,"ALL","0 Days","28 Days",{"count":20,"type":21},630,"ESTIMATED","OBSERVATIONAL","This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.",[25,26,27,28,29],"Congenital Cytomegalovirus","Cytomegalovirus Infections","Neonatal Infection","Sensorineural Hearing Loss","Viral Infection","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-09","ACTUAL",{"date":36,"type":34},"2026-04-21",{"date":38,"type":21},"2026-12-31",{"name":40,"class":41},"Rigshospitalet, Denmark","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":15,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":70},"100537863","phase-1-comparing-single-versus-repeat-nmt-on-the-diversity-of-the-neonatal-nasal-microbiome-100537863","NCT06283355","Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome","Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome","Inclusion Criteria:\n\nNeonate:\n\n1. Neonate has anticipated NICU length of stay \\> 7 days\n2. Neonate ≥25 weeks gestation\n3. At least one parent\u002Fadult provider not colonized with S. aureus (as determined by baseline screening)\n4. Neonate is not colonized with S. aureus on baseline screening\n\nParent\u002FAdult provider:\n\n1\\. Parent\u002FAdult provider is able to provide informed consent\n\nExclusion Criteria:\n\nNeonate:\n\n1. Neonate has had a prior clinical or surveillance culture grow S. aureus\n2. Neonate is a ward of the State\n3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)\n4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)\n\nParent\u002FAdult provider:\n\n1. Parent\u002Fadult provider had positive COVID-19 test in prior 21 days\n2. Parent\u002Fadult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)\n3. Parent\u002Fadult provider has been in close contact with someone in the last 7 days who had a respiratory viral infection, like the cold or the flu?\n4. Parent\u002Fadult provider tests positive on baseline screening test for S. aureus nasal colonization.\n5. Parent\u002Fadult provider tests positive on baseline screening test for a respiratory pathogen.\n6. Parent\u002Fadult provider is not able to provide written informed consent\n7. Parent\u002Fadult provider is not able to be present at the bedside at the time of intervention.\n8. Parent\u002Fadult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.\n9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire","0 Years","60 Years",{"count":53,"type":21},175,"INTERVENTIONAL",[56],"PHASE1","This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.",[59,60,27],"Staphylococcus Aureus","Microbial Colonization",[62],"microbiome",{"date":64,"type":34},"2026-06-08",{"date":66,"type":34},"2024-09-03",{"date":38,"type":21},{"name":69,"class":41},"Johns Hopkins University",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":70},"100413513","national-bacterial-meningitis-study-in-children-and-newborns-100413513","NCT04664569","National Bacterial Meningitis Study in Children and Newborns","National Observatory of Bacterial Meningitis in Children and Newborns","Inclusion Criteria:\n\n* clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and\u002For positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and\u002For positive CSF polymerase chain reaction (PCR), and\u002For positive blood culture with CSF pleocytosis (\\> 10 cells\u002FµL).\n* purpura fulminans\n\nExclusion Criteria:\n\n\\-","1 Day","18 Years",{"count":81,"type":21},10000,"Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.",[84,85,86,87,88,27,89,90],"Meningitis","Children, Only","Pneumococcal Conjugate Vaccine","Meningococcal Vaccines","H. Influenzae Vaccine","Antibiotic Treatment","Case Fatality Rate","2026-04-23",{"date":93,"type":34},"2026-04-28",{"date":95,"type":34},"2001-01-01",{"date":97,"type":21},"2030-01-01",{"name":99,"class":41},"Association Clinique Thérapeutique Infantile du val de Marne",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":54,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":70},"100523925","phase-3-zinc-supplementation-for-young-infants-with-clinical-severe-infection-in-tanzania-100523925","NCT06102044","Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania","Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania","Inclusion Criteria:\n\n* Young infants aged 0-59 days\n* Diagnosis of clinical severe infection (CSI)\n* Ability to feed enterally\n* Intend to stay in the study area for 90 days\n* Provided informed consent\n\nExclusion Criteria:\n\n* Prior use of zinc supplements during the current illness\n* Receipt of antibiotics for \\>24 hours before enrollment\n* Diarrhea at enrollment\n* Signs suggestive of serious illness\u002Fcondition that is not clinical severe infection\n* Previously enrolled in the trial\n* Enrolled in other research study","59 Days",{"count":109,"type":21},3250,[111],"PHASE3","Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection.\n\nThe Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.",[27],"2025-12-05",{"date":116,"type":34},"2025-12-12",{"date":118,"type":34},"2024-12-27",{"date":120,"type":21},"2027-10-30",{"name":122,"class":41},"Harvard School of Public Health (HSPH)",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":70},"100425347","peripheral-fractional-tissue-oxygen-extraction-and-infection-in-term-and-preterm-neonates-100425347","NCT04818762","Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates","Peripheral Fractional Tissue Oxygen Extraction and Infection in Term and Preterm Neonates - a Prospective Pilot Observational Study","pFTOE","Inclusion Criteria:\n\n* Signs of respiratory distress at time-point of inclusion (tachypnoea \\>60\u002Fminutes, grunting, intercostal\u002Fsubcostal\u002Fjugular retractions, nasal flaring, supplemental oxygen or respiratory upport)\n* Decision to conduct full life support\n* Written informed consent\n* Age \\\u003C 6 hours\n\nExclusion Criteria:\n\n* No decision to conduct full life support\n* no written informed consent\n* gestational age \\\u003C30+0 weeks of gestation\n* age \\> 6 hours\n* severe congenital malformations, severe asphyxia (umbilical cord artery pH \\\u003C7.00)","6 Hours",{"count":133,"type":21},80,"This is a prospective observational pilot study investigating if peripheral fractional tissue oxygen extraction (pFTOE) measured by five short near-infrared spectroscopy (NIRS) (re-)applications within the first 6 hours after birth in neonates with respiratory distress differs in neonates with early onset infection and neonate without infection",[27,136],"Preterm Birth","2025-03-12",{"date":139,"type":34},"2025-03-13",{"date":141,"type":34},"2021-02-26",{"date":143,"type":21},"2026-02-01",{"name":145,"class":41},"Medical University of Graz",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100566509","impact-of-a-multi-infusion-strategy-in-neonatology-on-the-rate-of-central-line-associated-bloodstream-infections-100566509","NCT06656104","Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections","EDELVAISS","Inclusion Criteria:\n\n* Gestational age at birth ≤ 32 weeks\n* Birthweight ≤ 1600 g\n* Admitted in the first 3 days of life in the neonatal unit\n* Hospitalized in the neonatal unit for at least 1 day\n* Survived the first three days of life\n* Requires the use of infusion sets for the administration of multiple drugs or solutions, whether or not they have the device in place\n* Receipt of the non-opposition from parents or guardians\n\nExclusion Criteria:\n\n* Opposition by parents or guardians\n* Lethal or complicated malformation\n* Chromosomal anomaly\n* Participation of the infant in any other research that may interfere with the results of this study, in the judgment of the investigator","32 Weeks",{"count":155,"type":21},455,"The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable. IV administration requires the use of a central venous catheter and an infusion set that connects the catheter to the infusion fluid or drug. The use of multiple infusion devices exposes patients to central line-associated bloodstream infections (CLABSI), drug interactions, abnormal administration timing and repetition of procedures in close proximity to the infant.\n\nAgainst this backdrop, DORAN INTERNATIONAL has developed the EDELVAISS multi-infusion strategy (Multiline Neo® and Escape Line® devices) adapted to neonatology. Given its characteristics, the benefits expected from the use of this strategy are: 1) to reduce the risk of microbial contamination and therefore the number of nosocomial infections 2) reduce exposure to antibiotics used in late sepsis 3) reduce the number of central line losses due to catheter obstruction 4) reduce dys-stimulating procedures in contact with the infant and 5) reduce staff stress.\n\nA pilot study before (year 2019) and after (year 2020) was carried out in the tertiary care neonatal unit at Croix-Rousse hospital. The baseline CLABSI rate was slightly below the national level of the last French survey (12.4\u002F1000 catheter days \\[95%CI:10.8;14.0\\]). In 322 very-low-birth-weight infants, the investigators showed a significant 88% reduction in the rate of catheter-related bacteremia, from 11.3 to 2.2 infections per 1,000 catheter-days after implementation of the EDELVAISS multi-infusion strategy.\n\nSince this pilot study, the EDELVAISS multi-infusion strategy has been used routinely in the neonatology department for around 2,000 infants admitted to the neonatology department at Croix-Rousse hospital. The low CLABSI rate observed in 2020 was maintained over the following 2 years. Several tertiary care neonatology departments have implemented the EDELVAISS multi-infusion strategy (ten departments have already done so, and five are in the process of doing so). The three neonatal units that agreed to take part in the EDELVAISS study also wish to implement the EDELVAISS multi-infusion strategy.\n\nThe invetsigators hypothesize that the reduction in CLABSI rates observed in the neonatal unit at Croix-Rousse hospital during the pilot study will be found in other French neonatal units, whatever the initial practices and devices used in each center.",[27],[159,160,161,162,163],"neonatal infection","prematurity","catheter","parenteral","perfusion","2025-01-20",{"date":166,"type":34},"2025-01-22",{"date":168,"type":34},"2025-01-14",{"date":170,"type":21},"2026-11-01",{"name":172,"class":41},"Hospices Civils de Lyon",3,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":54,"phases":184,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":70},"100216571","phase-4-exploring-vancomycin-disposition-in-neonates-100216571","NCT02096536","Exploring Vancomycin Disposition in Neonates","Exploring Vancomycin Disposition in Neonates: Paired Analysis of Vancomycin Concentrations Using Immunoassay and Liquid-chromatography-tandem Mass Spectrometry. Determination of Vancomycin Protein Binding and Its Covariates in Neonates","Inclusion Criteria:\n\n* Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is administered for medical reasons, can be included in the study after informed consent of the parents.\n\nExclusion Criteria:\n\n* No vancomycin therapy\n* No signed informed consent available","23 Months",{"count":183,"type":21},120,[185],"PHASE4","Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.",[27],[189,190,191,192],"Neonate","Vancomycin","LC\u002FMS-MS","protein binding","2024-07-11",{"date":195,"type":34},"2024-07-12",{"date":197,"type":4},"2014-04",{"date":199,"type":21},"2025-01",{"name":201,"class":41},"Universitaire Ziekenhuizen KU Leuven",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":210,"minAge":79,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":70},"100501740","prenatal-antibiotics-and-breast-milk--neonatal-iga-100501740","NCT05813184","Prenatal Antibiotics and Breast Milk \u002F Neonatal IgA","Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA","PAIGAN 1","Inclusion Criteria:\n\n* expression of written informed consent\n* an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group)\n* the intention to breastfeed their neonates as long as possible during the first year of life\n\nExclusion Criteria:\n\n* absence of written informed consent\n* the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding)\n* a maternal antibiotic treatment shorter than 7 days\n* the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases)\n* a delivery at a gestational age \\\u003C 34 weeks\n* the administration of antibiotics to neonates after birth, within the first week of life.","FEMALE","40 Years",{"count":213,"type":21},82,"In this biological study, the investigators will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation",[216,217,218,27,219],"Prenatal Exposure Delayed Effects","Antibiotic Prophylaxis","Dysbiosis","Breast Milk; Noxious Influence, Affecting Fetus",[221,222,223,224,225],"IgA","Prenatal antibiotics","breast milk","feces","neonatal immune system","2024-06-24",{"date":228,"type":34},"2024-06-26",{"date":230,"type":34},"2023-10-08",{"date":232,"type":21},"2025-10-30",{"name":234,"class":41},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":18,"studyType":22,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":70},"100496304","neonatal-infection-surveillance-database-100496304","NCT05742490","Neonatal Infection Surveillance Database","neonIN","Inclusion Criteria:\n\n* Infants on participating Neonatal Units who have an episode of infection with a positive culture\n\nExclusion Criteria:\n\n\\-","1 Minute","12 Months",{"count":245,"type":21},12000,"NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.",[27],"2023-02-14",{"date":250,"type":34},"2023-02-24",{"date":252,"type":34},"2013-12-16",{"date":254,"type":21},"2028-11-22",{"name":256,"class":41},"St George's, University of London"]