[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newborn-morbidity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newborn-morbidity":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,86,115,146,171,193],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":46,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100569405","advanced-wireless-sensors-for-neonatal-care-in-the-delivery-room-100569405",false,"NCT06693817","Advanced Wireless Sensors for Neonatal Care in the Delivery Room","Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study","AWARD","Inclusion criteria:\n\n1. Newborns ≥35 weeks (gestational age)\n2. Newborns determined to be clinically stable at delivery\n3. Newborns with no skin abnormalities\n\nExclusion criteria:\n\n1. Newborns ≤ 35 weeks (gestational age)\n2. Newborns determined to not be clinically stable at delivery\n3. Newborns with Skin abnormalities",true,"ALL","35 Weeks","42 Weeks",{"count":22,"type":23},600,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:\n\n1. Assess feasibility\n2. Evaluate safety\n3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Sudden Unexplained Infant Death","Apnea of Newborn","Newborn Morbidity","Newborn Asphyxia","Birth Outcome, Adverse","Birth Asphyxia","Pregnancy Related","Newborn; Vitality","ECG Electrode Site Reaction","Infant ALL","Infant Death","Infant, Newborn, Diseases","Infant Apnea","Infant Conditions","Parents","Delivery Problem for Fetus","Delivery Complication",[47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Delivery Room","Newborn","Neonatal Resuscitation","Wireless Technology","Vital Sign Monitoring","Sudden Unexplained Post-Natal Collapse","SUPC","Obstetrical Center","Obstetrics","Neonate","Birth","Birthing Center","C-Section","Vaginal Delivery","Sensors","Heart Rate (HR)","Respiratory Rate (RR)","Blood Oxygen Saturation (SpO2)","Skin Temperature (Tskin)","Pulse Rate (PR)","International","Low-Income","Middle-Income","High-Income","Golden Hour","Post-Birth","RECRUITING","2026-05-05",{"date":76,"type":77},"2026-05-08","ACTUAL",{"date":79,"type":77},"2025-04-08",{"date":81,"type":23},"2027-12-30",{"name":83,"class":84},"Guilherme Sant'Anna, MD","OTHER",5,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":17,"sex":18,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":24,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100584610","blood-phoenixin-14-levels-and-echocardiographic-findings-in-infants-of-diabetic-mothers-100584610","NCT06891586","Blood Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers","Investigation of the Relationship Between Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers","Inclusion Criteria:\n\n* Infants of diabetic mothers\n* Healthy term infants\n\nExclusion Criteria:\n\n* Infants whose families did not provide consent\n* Infants with a syndromic appearance or congenital heart disease","1 Day","5 Days",{"count":96,"type":23},84,[26],"In this study, the investigators hypothesize that echocardiographic pathologies observed in infants of diabetic mothers are associated with elevated serum phoenixin-14 levels.",[31,100],"Newborn Complication",[102,103,104],"NEWBORN","phoenixin-14","Infants of Diabetic Mothers","2026-03-26",{"date":107,"type":77},"2026-03-27",{"date":109,"type":77},"2024-09-01",{"date":111,"type":23},"2026-10-01",{"name":113,"class":84},"Konya City Hospital",1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":24,"phases":125,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":85},"100586445","phase-2-efficacy-of-direct-catheterisation-of-the-ombilical-vein-in-emergency-through-whartons-jelly-100586445","NCT06915467","Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly","Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly in the Delivery Room: Multicentre Study","CaDOm","Inclusion Criteria :\n\n* Full-term newborn (≥ 37 SA)\n* Newborn for whom a resuscitation decision has been taken.\n* Newborn in circulatory arrest, or in profound bradycardia \\\u003C 60 bpm, requiring an injection of adrenaline in the delivery room, the indication being established in accordance with the recommendations of the European Resuscitation Council 2021, after completion of the first stages of cardiopulmonary resuscitation, including the establishment of effective ventilation\n* Newborn beneficiary of a social security scheme or entitled person.\n\nNon-inclusion Criteria :\n\n* Newborn with known heart defects or other potentially lethal defects\n* Presence of a pre-existing access route\n* Paediatric resuscitator not trained to the UVW procedure\n* Twins born in circulatory arrest and requiring simultaneous management",{"count":124,"type":23},26,[126],"PHASE2","The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situations in the delivery room.",[31],[130,131,132,133,134,135],"Cardiorespiratory arrest","Newborns","Umbilical Venous Catheter","Wharton's jelly","Neonatal resuscitation","Adrenaline injection","NOT_YET_RECRUITING","2025-09-08",{"date":139,"type":77},"2025-09-09",{"date":141,"type":23},"2025-09",{"date":143,"type":23},"2027-10",{"name":145,"class":84},"Hôpital NOVO",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":17,"sex":154,"minAge":4,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":114},"100393642","measuring-adverse-pregnancy-and-newborn-congenital-outcomes-100393642","NCT04405700","Measuring Adverse Pregnancy and Newborn Congenital Outcomes","Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study","MANGO","C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:\n\nInclusion criteria for women\n\n1. Pregnant and enrolled in ANC at the study site;\n2. Understands English or Swahili.\n\nExclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent\n\nInclusion criteria for infants\n\na. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)\n\nC2. Data collection for all deliveries at the site:\n\nInclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site\n\nExclusion criteria for women (none)\n\nInclusion criteria for live\u002Fstillborn infants\n\na. Infant is delivered at the site and results in the infant\u002Fstillbirth being registered at the site\n\nExclusion criteria for infants (none)\n\nC3. Photos\u002Fvideos of infants with CAs:\n\nInclusion criteria for infants\n\n1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age\n2. The infant has a suspected CA on surface exam\n\nExclusion criteria for infants (none)","FEMALE",{"count":156,"type":23},2800,"OBSERVATIONAL","The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).",[160,35,161,31],"HIV\u002FAIDS","Congenital Disorders","2025-08-15",{"date":164,"type":77},"2025-08-19",{"date":166,"type":77},"2020-09-29",{"date":168,"type":23},"2026-05-31",{"name":170,"class":84},"Indiana University",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":18,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":114},"100522319","newborn-genomics-programme-100522319","NCT06081075","Newborn Genomics Programme","Inclusion Criteria:\n\n* Acutely ill inpatient\n* Admitted to NICU or PICU between April 2023 - March 2026\n* Within 1 week of hospitalization or within 1 week of development of abnormal response to standard therapy for an underlying condition\n* Suspected genetic condition, without a clear non-genetic aetiology\n\nExclusion Criteria:\n\n* Patients whose clinical course is entirely explained by\n* Isolated prematurity\n* Isolated unconjugated hyperbilirubinemia\n* Infection or sepsis with expected response to therapy\n* A previously confirmed genetic diagnosis that explains the clinical condition -\n* Isolated transient neonatal tachypnoea\n* Meconium aspiration syndrome\n* Trauma\n* Inability to source blood and buccal samples for DNA extraction from at least the mother and child","0 Hours","2 Years",{"count":180,"type":23},500,"Genomic methods can significantly contribute to all facets of precision medicine, from diagnosis to prevention, therapeutic intervention, and management of acute and chronic illnesses. DNA based methods are already having a considerable impact across healthcare in fields that include: public health, infectious disease monitoring, acute and chronic disease, pharmacogenomics, prenatal testing and diagnosis, and therapeutic development. In this proposal, investigators are focusing on the application of genomic methods in precision medicine - specifically on rapid whole-genome sequencing of parents and children (i.e. a trio) for the identification of diseases that have genetic components.\n\nGoals Primary goal: is to provide safe rapid whole genome sequencing to Neonatal Intensive Care Unit\u002FPediatric Intensive Care Unit patients.\n\nSecondary goals: 1) Although several groups globally are implementing rapid sequencing of rare disease, these are predominantly in the research space, with many unanswered questions regarding the best way to implement them into a national healthcare system. Each country and their healthcare systems are unique, and valuable knowledge will be gained by implementing this process within a New Zealand context. As part of this the study will measure the impact on the individuals and families.\n\n2\\) to expand the research team's understanding of non-coding disease-causing variants and methylation changes that contribute to severe disease in early life.\n\nPrimary Aims\n\n1. To incorporate long-read RNA sequencing data into the diagnostic rapid Whole Genome Sequencing pipeline to provide a direct measure of the functional outcome of the variants of clinical concern.\n2. To measure the clinical utility of analysing non-coding variants in the diagnosis of critically ill children who do not have pathogenic, likely pathogenic, or variants of unknown significance for mendelian disorders.\n3. To identify, in a real-world setting within the New Zealand health-care system, the clinical and economic effects of deploying rapid Whole Genome Sequencing-informed rapid precision medicine for critically ill children.",[183,31],"Genetic Disease","2025-05-04",{"date":186,"type":77},"2025-05-07",{"date":188,"type":77},"2024-01-15",{"date":190,"type":23},"2027-12",{"name":192,"class":84},"Liggins Institute",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":17,"sex":18,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":114},"100535790","effects-of-confortable-environment-kangaroo-care-and-music-therapy-in-newborns-in-neonatal-intensive-care-unit-100535790","NCT06256406","Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit","Comparative Evaluation Between Preterms and Newborns Undergoing Surgery. Effectiveness of a Multimodal Sensory Intervention on Newborns and Parents' Stress","PRE-CARE","Inclusion Criteria:\n\n* newborn hospitalized in NICU\n\nExclusion Criteria:\n\n* not hospitalized in NICU,\n* intubated infants,\n* instable clinical condition","0 Days","3 Years",{"count":204,"type":23},50,[26],"Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU). These strategies not only contribute to the physical well-being of the infants but also play a significant role in promoting their emotional and developmental health.",[208,31],"Premature Infant Disease",[48,210,211,212],"Kangaroo-Mother Care Method","Music Therapy","Intensive Care Units, Neonatal","2024-02-04",{"date":215,"type":77},"2024-02-13",{"date":217,"type":77},"2022-06-20",{"date":219,"type":23},"2026-12-31",{"name":221,"class":84},"Policlinico Universitario, Catania"]