[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extreme-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extreme-prematurity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,79,111,138,163,191,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100616592","phase-1-high-energy-human-milk-diets-in-the-first-two-weeks-after-birth-to-reduce-bpd-in-extremely-preterm-infants-100616592",false,"NCT07307612","High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants","Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial","MEND-BPD","Inclusion Criteria:\n\n* Gestational age ≤ 28 weeks of gestation\n* Postnatal age \\\u003C 72 hours\n\nExclusion Criteria:\n\n* Congenital malformations\n* Chromosomal anomalies\n* Terminal illness needing to limit or withhold support","ALL","1 Day","3 Days",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA\u002FARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).",[29,30,31],"Extreme Prematurity","Enteral Nutrition","Bronchopulmonary Dysplasia",[33],"Prematurity; Extreme","NOT_YET_RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-12","ACTUAL",{"date":40,"type":22},"2026-08-15",{"date":42,"type":22},"2029-07-31",{"name":44,"class":45},"University of Alabama at Birmingham","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":46},"100555503","ventilator-pressure-and-optimization-of-compliance-and-hemodynamics-100555503","NCT06512935","Ventilator Pressure and Optimization of Compliance and Hemodynamics","Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial","VPOCH","Inclusion Criteria:\n\nPreterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \\\u003C 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.\n\n* Post-natal age \\> 7 days and less than 1 month (outside golden week protocol)\n* Gestational age ≥ 21 weeks and ≤ 34 week\n* Infants with written informed consent obtained from legal guardian\n\nExclusion Criteria:\n\n* Blood culture-positive sepsis\n* Congenital anomalies affecting respiration\n* Cyanotic or ductal-dependent congenital heart disease\n* Newborns who are considered too unstable for study enrolment per neonatology attending\n* Newborns on pressors or steroids for maintaining cardiac output\n* Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)\n* Open skin wounds or abrasions on the chest wall.","7 Days","30 Days",{"count":58,"type":22},24,[60],"NA","In preterm infants \\\u003C 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants.\n\nInfants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.",[31,63,29,64,65],"Pulmonary Hypertension Due to Lung Diseases and Hypoxia","Ventilator Lung; Newborn","Ventilation Perfusion Mismatch",[67,68,69],"Respiratory distress syndrome","ventilation mechanics in newborn","cardiac hemodynamics newborn","RECRUITING","2026-05-06",{"date":73,"type":38},"2026-05-11",{"date":75,"type":22},"2026-08-01",{"date":77,"type":22},"2027-06-30",{"name":44,"class":45},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"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":90,"type":22},500,[26],"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.",[29,94,95],"Intraventricular Hemorrhage","Morbidity;Newborn",[97,98,99,100],"extremely preterm","severe intraventricular hemorrhage","mortality","prophylactic indomethacin","2025-08-26",{"date":103,"type":38},"2025-09-03",{"date":105,"type":22},"2025-11-01",{"date":107,"type":22},"2031-03-31",{"name":109,"class":45},"University of British Columbia",15,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":122,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100465939","dopamine-vs-norepinephrine-for-hypotension-in-very-preterm-infants-with-late-onset-sepsis-100465939","NCT05347238","Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis","Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis: An International Comparative Effectiveness Research Project","Inclusion Criteria:\n\n* ≤32 weeks gestational age and \\> 48 hours of life\n* Receiving primary vasopressor therapy with Dopamine or Norepinephrine in the context of suspected late-onset sepsis or necrotizing enterocolitis with systemic hypotension (defined as: culture positive or negative bloodstream infection)\n\nExclusion Criteria:\n\n* Known chromosomal or genetic anomalies\n* Receiving primary therapy with agents other than Dopamine or Norepinephrine","21 Weeks","32 Weeks",{"count":121,"type":22},550,"36 Weeks","OBSERVATIONAL","Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or necrotizing enterocolitis occurring \\>48 hours of age). In Canada, \\~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these \\~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices.\n\nAim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS.\n\nObjective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacotherapy for fluid-unresponsive hypotension in preterm infants born ≤ 32 weeks gestational age with suspected LOS.\n\nHypothesis: Primary treatment with NE will be associated with a lower mortality\n\nMethods: This CER project will compare management approach at the unit-level allowing inclusion of all eligible patients admitted during the study period. 16 centers in Canada, 2 centers in Ireland, 1 center in each of Israel, Spain and the UK, and 6 centers in the United States have agreed to standardize their practice. All eligible patients deemed circulatory insufficient will receive fluid therapy (minimum 10-20 cc\u002Fkg). If hypotension remains unresolved:\n\nDopamine Units: start at 5mics\u002Fkg\u002Fmin, increase every 16-30 minutes by 5 mics\u002Fkg\u002Fmin to a maximum dose of 15 mics\u002Fkg\u002Fmin or adequate response\n\nNorepinephrine Units: start at 0.05 mics\u002Fkg\u002Fmin, increase every 16-30 minutes by 0.05 mics\u002Fkg\u002Fmin to maximum dose of 0.15\u002Fmics\u002Fkg\u002Fmin or adequate response",[126,29,127],"Late-Onset Neonatal Sepsis","Neonatal Hypotension","2025-07-03",{"date":130,"type":38},"2025-07-08",{"date":132,"type":38},"2023-02-06",{"date":134,"type":22},"2027-03-31",{"name":136,"class":45},"Mount Sinai Hospital, Canada",23,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":46},"100384716","open-lung-maneuvers-during-high-frequency-oscillatory-ventilation-in-preterm-infants-100384716","NCT04289324","Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants","Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - A Single Center Randomized Controlled Trial","OPEN4HFOV","Inclusion Criteria: Preterm infants\n\n* born below 28 weeks of gestational age\n* not older than 29 weeks of postmenstrual age\n* receive HFOV\n\nExclusion Criteria:\n\n* known congenital anomalies of the heart, of the lung, and\u002For of the central nervous system\n* known chromosomal abnormalities\n* participation in other intervention trials","8 Weeks",{"count":148,"type":22},36,[60],"To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 \u002F peripheral Oxygen Saturation, OSI = MAPxFiO2x100\u002FSpO2) averaged over high frequency oscillation ventilation (HFOV) time in extremely preterm infants.",[152,29,153],"High Frequency Oscillation Ventilation","Lung Injury, Acute","2024-11-18",{"date":156,"type":38},"2024-11-20",{"date":158,"type":38},"2020-02-25",{"date":160,"type":22},"2025-12-31",{"name":162,"class":45},"Medical University of Vienna",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":46},"100533026","folic-acid-supplementation-to-reduce-anemia-in-extremely-preterm-infants-100533026","NCT06220461","Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants","Folic Acid Supplementation to Reduce the Severity of Anemia and Blood Transfusions in Extremely Preterm Infants","FASCINATE","Inclusion Criteria:\n\n* Infants born at \\\u003C29 weeks of gestational age admitted to Foothill Medical Centre.\n* Postnatal age 14 days.\n* On minimum enteral feeding of 100 mL\u002Fkg\u002Fday\n\nExclusion Criteria:\n\n* Infants with major congenital or chromosomal anomalies\n* Infants with ongoing pulmonary or gastroenterology hemorrhage by 14 days of life.",{"count":172,"type":22},90,[60],"Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants. Despite the adoption of folic acid supplementation, evidence supporting its effectiveness in preventing AOP remains scarce. Recommendations for folic acid intake exceed what's naturally found in breast milk, particularly for extremely low birthweight infants. Practices regarding folic acid supplementation vary widely, prompting the need for research. The FACINATE trial aims to determine if additional folic acid supplementation improves hemoglobin levels and reduces late blood transfusions in extremely preterm infants, a question not addressed in current literature.",[29,176],"Anemia of Prematurity",[178,179,180,181],"extreme preterm","folic acid deficiency","anemia of prematurity","neonatal blood transfusion","2024-05-08",{"date":184,"type":38},"2024-05-09",{"date":186,"type":22},"2024-06-01",{"date":188,"type":22},"2028-07-31",{"name":190,"class":45},"University of Calgary",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":210,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100518215","early-intervention-based-on-neonatal-crawling-in-very-premature-infants-at-risk-for-neurodevelopmental-disorder-100518215","NCT06027645","Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder","Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder","Premalocom2","Inclusion Criteria:\n\n* Term between 24-26 GA or 26-32 GA with suspected brain lesion\n* parental consent\n* family living in intervention area\n* good tolerance on the first crawliskate trial\n\nExclusion Criteria:\n\n* no bronchodysplasia defined by oxygen dependency after 36 GA\n* no medical disease\n* no limb deformity\n* no karyotype anomaly\n* no visual or auditory impairment","39 Weeks","42 Weeks",{"count":202,"type":22},50,[60],"Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.\n\nThe specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and\u002For neuropsychological development in very premature infants identified as high risk for developmental delay.\n\nMethodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions.\n\nThese infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.\n\nExpected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.",[206,29,207,208,209],"Prematurity","Infant Development","Brain Damage","Motor and Developmental Delay",[206,211,212,213,214],"Crawling","Early intervention","Motor development","Locomotion","2023-09-08",{"date":217,"type":38},"2023-09-13",{"date":219,"type":38},"2021-03-29",{"date":221,"type":22},"2029-12-31",{"name":223,"class":45},"Marianne Barbu-Roth",3,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":240,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":46},"100476917","the-pilot-experimental-study-of-the-neuroprotective-effects-of-exosomes-in-extremely-low-birth-weight-infants-100476917","NCT05490173","The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants","Inclusion Criteria:\n\n• Premature newborns of gestational age (GA) 25\u002F0-27\u002F6 weeks,\n\nExclusion Criteria:\n\n* Missing written parental consent\n* Damages to the nasal mucosa\n* Maxillofacial defects\n* Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period)\n* Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable\n* Infants with edematous hemolytic disease of newborns, non-immune fetal dropsy,\n* Multifetal Gestations\n* Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study",{"count":232,"type":22},10,[60],"To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25\u002F0-27\u002F6 weeks.",[236,29,237,238,239],"Premature Birth","Preterm Intraventricular Hemorrhage","Hypoxia-Ischemia, Cerebral","Neurodevelopmental Disorders",[241],"Extremely low birth weight, neuroprotection","2022-09-26",{"date":244,"type":38},"2022-09-28",{"date":246,"type":22},"2022-10-05",{"date":248,"type":22},"2026-12-28",{"name":250,"class":251},"Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare","OTHER_GOV"]