[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"morbiditynewborn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:morbiditynewborn":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100522792","the-teleneo-trial-a-multicenter-trial-of-telemedicine-for-advanced-neonatal-resuscitations-in-community-hospitals-100522792",false,"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.","ALL","0 Days",{"count":18,"type":19},947,"ESTIMATED","INTERVENTIONAL",[22],"NA","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.",[25,26],"Death; Neonatal","Morbidity;Newborn",[28,29,30],"Telemedicine","Newborn","Resuscitation","RECRUITING","2025-11-18",{"date":34,"type":35},"2025-11-21","ACTUAL",{"date":37,"type":35},"2024-03-05",{"date":39,"type":19},"2029-05-01",{"name":41,"class":42},"Mayo Clinic","OTHER",36,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100560113","phase-2-single-dose-prophylactic-indomethacin-in-extremely-preterm-infants-100560113","NCT06572917","Single-dose Prophylactic INdomethacin in Extremely Preterm Infants","Single-dose Prophylactic INdomethacin in Extremely Preterm Infants - A Multicenter Randomized Blinded Placebo-Controlled Trial (the SPIN RCT)","SPIN","Inclusion Criteria:\n\n* Extremely preterm infants born \\\u003C26 completed weeks of GA and\u002For extremely low BW infants born \\\u003C750g\n\nExclusion Criteria:\n\n* antenatal diagnosis of duct dependent CHD\n* acute hypoxic respiratory failure \\[defined as fraction of inspired oxygen (FiO2)\\>0.60 for ≥2h)\n* inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary hypertension (PH)\n* receipt of prophylactic or therapeutic hydrocortisone\n* antenatal diagnosis of renal anomalies\n* initial platelet count \\\u003C50x109\u002FL\n* decision to withhold\u002Fwithdraw life-sustaining treatments","0 Hours","12 Hours",{"count":55,"type":19},500,[57],"PHASE2","In Canada, about 900 babies each year are born very early (\\\u003C26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.\n\nThe investigators propose a blinded randomized controlled trial, a study design where babies born \\\u003C26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.\n\nThe investigators will conduct the study in multiple NICUs across Canada, the United States and Australia in 2 phases: First, an internal pilot phase that will enroll 104 babies born \\\u003C26 weeks or \\\u003C750 g birth weight over a period of 1 year. If the investigators are successful in achieving their target enrolment in the pilot phase, they will move on to the second phase and continue enrollment up to a total of 500 babies born \\\u003C26 weeks or \\\u003C750 g birth weight over a period of 3 years. The total of 500 babies will include the 104 babies enrolled in the first phase of the study. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born \\\u003C26 weeks of gestation can safely and effectively reduce severe brain bleeding.",[60,61,26],"Extreme Prematurity","Intraventricular Hemorrhage",[63,64,65,66],"extremely preterm","severe intraventricular hemorrhage","mortality","prophylactic indomethacin","NOT_YET_RECRUITING","2025-08-26",{"date":70,"type":35},"2025-09-03",{"date":72,"type":19},"2025-11-01",{"date":74,"type":19},"2031-03-31",{"name":76,"class":42},"University of British Columbia",15]