[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"death-neonatal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:death-neonatal":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,60,88],{"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":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100631599","heterologous-cord-blood-derived-red-blood-cell-for-transfusion-in-extremely-preterm-infants-100631599",false,"NCT07502781","Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants","Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants","Inclusion Criteria:\n\n* Signed informed consent obtained from parents or legal guardians.\n* Gestational age at birth \\\u003C 28 weeks or birth weight \\\u003C 1000 g.\n* Admission to one of the participating neonatal intensive care units (NICUs) in the Barcelona area.\n\nExclusion Criteria:\n\n* Prior red blood cell transfusion during the fetal or neonatal period.\n* Maternal-fetal immunization (e.g., isoimmunization).\n* Fetal hydrops.\n* Major congenital malformations.\n* Congenital infections.\n* Immediate need for blood before randomization (e.g., hemorrhagic shock, consumptive coagulopathy).\n* Participation in another clinical trial that could interfere with the primary outcome.","ALL","23 Weeks","28 Weeks",{"count":20,"type":21},176,"ESTIMATED","INTERVENTIONAL",[24],"NA","Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red blood cell transfusions during their hospital stay.\n\nCurrently, transfusions are given using red blood cells donated by adults. An alternative option is to use red blood cells collected from umbilical cord blood, which may be more similar to a newborn's own blood. This approach has been used in some neonatal units with encouraging results and no reported safety concerns.\n\nThis study aims to determine whether transfusion with umbilical cord blood improves clinical outcomes and reduces potential side effects compared to standard adult donor blood transfusion in extremely preterm infants. We hypothesize that umbilical cord blood transfusion will be at least as safe as adult donor blood and may provide clinical benefits.\n\nAbout 115 extremely preterm infants admitted to neonatal units in Catalonia will participate. If parents agree, their baby will be randomly assigned to receive either compatible umbilical cord blood or compatible adult donor blood if a transfusion becomes necessary. Babies will only receive a transfusion if they clinically need one. If cord blood is not available at the time of transfusion, the baby will receive compatible adult donor blood regardless of the assigned group.\n\nTo evaluate the response to treatment, small blood samples will be collected at birth, at one month of life, and 24 hours after any transfusion. These samples are taken at the same times as routine blood tests, so participation does not require additional needle sticks. The amount of blood collected is minimal (about 0.2 mL per sample).\n\nIn addition, a painless and non-invasive sensor will be placed on the baby's head for 24 hours to measure oxygen delivery to the brain. Urine samples will also be collected before and after transfusion to help assess how oxygen reaches body tissues.\n\nParticipation will continue until the baby reaches 36 weeks of postmenstrual age or is discharged from the hospital, whichever comes first.",[27,28,29,30,31,32,33,34,35],"Extremely Premature Infant","Anemia Neonatal","Blood Transfusion","Umbilical Cord Blood","Fetal Hemoglobin","Bronchopulmonary Dysplasia (BPD)","Retinopathy of Prematurity (ROP)","Death; Neonatal","Intensive Care Units, Neonatal",[37,38,39,40,41,42,43,44,45,46],"Cord blood red blod cell transfusion","Umbilical cord blood transfusion","Extremely preterm infants","Neonatal anemia","Fetal hemoglobin","Adult donor red blood cells","Bronchopulmonary dysplasia","Retinopathy of prematurity","Oxygen delivery","Days requiring oxygen supplementation","NOT_YET_RECRUITING","2026-03-27",{"date":50,"type":51},"2026-03-31","ACTUAL",{"date":53,"type":21},"2027-01",{"date":55,"type":21},"2029-12",{"name":57,"class":58},"Hospital Clinic of Barcelona","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100522792","the-teleneo-trial-a-multicenter-trial-of-telemedicine-for-advanced-neonatal-resuscitations-in-community-hospitals-100522792","NCT06087224","The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals","Inclusion Criteria:\n\nGROUP 1: Community hospital clinicians\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. A clinician who attends newborn resuscitations at a participating community hospital spoke site.\n2. Provision of informed oral consent prior to any mandatory study specific procedures and analyses.\n\nGROUP 2: At-risk outborn neonates To be eligible for this study, a neonate born in a participating community hospital spoke site must meet \\*at least one\\* of the following inclusion criteria\n\n1. Preterm birth at less than 32 weeks' gestation at delivery; OR\n2. Need for advanced resuscitation defined as:\n\n   1. positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR\n   2. placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR\n   3. chest compressions.\n\nExclusion Criteria:\n\nGROUP 1: Community hospital clinicians None\n\nGROUP 2: At-risk outborn neonates\n\nA neonate born in a participating community hospital spoke site who meets any of the following criteria will be excluded from the study:\n\n1. Birth outside of the hospital birthing center.\n2. Neonatal transport team present at time of birth and providing resuscitative care.\n3. Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life.\n4. Plan for comfort care (non-resuscitation) following delivery.\n5. In-person neonatology-trained physician present for the resuscitation.","0 Days",{"count":68,"type":21},947,[24],"The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.",[34,72],"Morbidity;Newborn",[74,75,76],"Telemedicine","Newborn","Resuscitation","RECRUITING","2025-11-18",{"date":80,"type":51},"2025-11-21",{"date":82,"type":51},"2024-03-05",{"date":84,"type":21},"2029-05-01",{"name":86,"class":58},"Mayo Clinic",36,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100513089","phase-3-infasurfaero-versus-sham-treatment-in-preterm-newborns-with-rds-100513089","NCT05960929","InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS","InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial","Aero-05","Inclusion Criteria:\n\nInclusion criteria include ALL of the following:\n\n1. Written informed consent obtained by parent or legal representative prior to or after birth\n2. Gestational age at birth ≥ 29 0\u002F7 AND ≤ 35 6\u002F7 weeks\n3. Birthweight ≥ 1,000 AND ≤ 3,500 grams\n4. Age ≥ 1 hour AND ≤ 6 hours\n5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation\n6. Require CPAP\n7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4\n8. If subject is \\>346\u002F7 weeks' gestation a chest radiograph is required\n\nExclusion Criteria:\n\nExclusion criteria are ANY of the following:\n\n1. Surfactant administration prior to randomization\n2. Mechanical ventilation prior to randomization\n3. Major congenital anomaly (suspected or confirmed)\n4. Abnormality of the airway (suspected or confirmed)\n5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)\n6. Apgar score \\\u003C 3 at 5 minutes of age\n7. Umbilical cord gas pH \\\u003C7.0 or BD \\> 10\n8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk","29 Weeks","36 Weeks",{"count":99,"type":21},220,[101],"PHASE3","The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.",[104,105,34],"Respiratory Distress Syndrome (Neonatal)","Intubation Complication",[107,108,109,110,111,112,113,114,115,116,117,118,119],"Infasurf","Calfactant","Inhalation","Nebulization","Preterm","InfasurfAero","Respiratory Distress Syndrome","Neonatal","NICU","CPAP","Intubation","Aerosol","CPAP Failure","2025-03-25",{"date":122,"type":51},"2025-03-30",{"date":124,"type":51},"2025-01-01",{"date":126,"type":21},"2026-04-01",{"name":128,"class":129},"ONY","INDUSTRY",10]