[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intraventricular-hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intraventricular-hemorrhage":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,51,81,114,151,187,210,240,270,299,326,350,377,401,430],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100377049","improving-outcomes-for-patients-with-life-threatening-neurologic-illness-100377049",false,"NCT04189471","Improving Outcomes for Patients With Life-Threatening Neurologic Illness","Recovery After Cerebral Hemorrhage--Improving Outcomes for Patients With Life-Threatening Neurologic Illness","REACH","Inclusion Criteria:\n\n* clinical diagnosis of potentially life-threatening neurological illness\n* admitted to Neuro ICU within 14 days of initial injury\n\nExclusion Criteria:\n\n* known pre-existing neurological deficits related to a developmental disorder\n* prior severe stroke\n* prior severe dementia\n* prior severe head injury\n* prisoners","ALL","18 Years",{"count":20,"type":21},5000,"ESTIMATED","12 Months","OBSERVATIONAL","Background:\n\nWhile the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support.\n\nThis can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies.\n\nPurpose:\n\nExamine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well.\n\nThis effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU.\n\nIn addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.",[26,27,28,29,30],"Intracerebral Hemorrhage","Subarachnoid Hemorrhage","Intraventricular Hemorrhage","Nontraumatic Haemorrhage","Status Epilepticus",[32,33,34,29,35,36,37],"hemorrhage","intracerebral hemorrhage","SAH","ICH","subarachnoid hemorrhage","status epilepticus","RECRUITING","2026-06-30",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2014-09-08",{"date":46,"type":21},"2034-01-01",{"name":48,"class":49},"University of Maryland, Baltimore","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100305213","phase-2-a-clinical-efficacy-and-safety-study-of-ohb-607-in-preventing-bronchopulmonary-dysplasia-in-extremely-premature-infants-100305213","NCT03253263","A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants","A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity","Inclusion Criteria:\n\n1. Written informed consents and\u002For assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB\u002FIEC (in accordance with local regulations).\n2. Written informed consents and\u002For assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB\u002FIEC (in accordance with local regulations).\n3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.\n\nExclusion Criteria:\n\n1. Detectable major (or severe) congenital malformation identified before randomization.\n2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.\n3. Hypoglycemia at Baseline (blood glucose less than (\\\u003C) 45 milligrams per deciliter \\[mg\u002FdL\\] or 2.5 milli moles per liter \\[mmol\u002FL\\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.\n4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.\n5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.\n6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).\n7. The participant or participant's parent(s) is\u002Fare unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.\n8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.\n9. Birth mother with known HIV or hepatitis (B, C, or E) infection.","0 Hours","24 Hours",{"count":61,"type":21},338,"INTERVENTIONAL",[64],"PHASE2","The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.",[67,68,28,69],"Bronchopulmonary Dysplasia","Chronic Lung Disease of Prematurity","Retinopathy of Prematurity (ROP)","2026-06-10",{"date":72,"type":42},"2026-06-11",{"date":74,"type":42},"2019-05-09",{"date":76,"type":21},"2028-01-21",{"name":78,"class":79},"OHB Neonatology Ltd.","INDUSTRY",72,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":62,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100639019","early-lumbar-drainage-for-intraventricular-hemorrhage-100639019","NCT07625449","Early Lumbar Drainage for Intraventricular Hemorrhage","Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial","LD-IVH","Inclusion Criteria:\n\n* Aged 18 to 85 years old, no limitation on gender.\n* First-ever intracerebral hemorrhage confirmed by CT\u002FMRI, accompanied by third and\u002For fourth intraventricular hemorrhage, requiring external ventricular drainage.\n* Baseline hemorrhage volume less than 30 mL, with stable clinical condition before randomization.\n* External ventricular drainage performed within 48 hours of symptom onset.\n* Randomization completed within 24 hours after EVD placement.\n* Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.\n* Written informed consent obtained from the participant or their legally authorized representative.\n\nExclusion Criteria:\n\n* Suspected or untreated ruptured intracranial aneurysm, arteriovenous malformation (AVM), or intracranial tumor, unless excluded by vascular imaging. Previously treated aneurysm or AVM must have been completed at least 3 months prior to enrollment.\n* Choroidal vascular malformation or moyamoya disease.\n\n  • Long-term oral anticoagulant use, persistent coagulation dysfunction, or known allergy to urokinase.\n* Platelet count \\\u003C 100×10⁹\u002FL or INR \\> 1.4.\n* Absolute contraindications to lumbar cistern drainage or external ventricular drainage, such as cerebral hernia or infection at the puncture site.\n* Infratentorial hemorrhage volume ≥ 10 mL.\n* Thalamic hemorrhage ≥ 10 mL, or accompanied by midbrain extension, oculomotor nerve palsy, or fixed dilated pupil.\n* Hemiplegia with muscle strength grade 0 or 1.\n* Active bleeding in the gastrointestinal, genitourinary, or respiratory system.\n* Multiple ecchymoses or petechiae suggesting a bleeding tendency.\n* Expected survival time less than 6 months.\n* Severe, untreatable concomitant systemic diseases.\n* Pregnancy.\n* Participation in other interventional clinical trials within 30 days prior to randomization.\n* Any other condition deemed inappropriate for enrollment by the investigator(s).","85 Years",{"count":91,"type":21},392,[93],"NA","This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial comparing the addition of early lumbar drainage to standard care in patients with intraventricular hemorrhage (IVH) in China. The primary objective is to evaluate whether early lumbar drainage improves long-term functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications in patients treated with external ventricular drainage (EVD) and intrathecal urokinase.",[28,96],"Cerebral Hemorrhage",[28,98,99,100,101,102],"Lumbar Drainage","External Ventricular Drainage","Urokinase","PROBE design","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-03",{"date":106,"type":42},"2026-06-04",{"date":108,"type":21},"2026-06",{"date":110,"type":21},"2029-10",{"name":112,"class":49},"Second Affiliated Hospital of Nanchang University",29,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":62,"phases":124,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100549078","phase-4-international-care-bundle-evaluation-in-cerebral-hemorrhage-research-100549078","NCT06429332","International Care Bundle Evaluation in Cerebral Hemorrhage Research","International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period","I-CATCHER","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage\n* ≤24 hours from symptom onset or presumed symptom onset (last seen well)\n\nExclusion Criteria:\n\n* Previous care limitation\n* End-stage comorbidity with short life-expectancy (\\\u003C6 m; e.g. terminal cancer)\n* ICH caused by brain tumor or cerebral venous thrombosis\n* Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)\n* Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.",{"count":123,"type":21},3500,[125],"PHASE4","Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.",[26,128,28,129,130],"Intracerebral Haemorrhage","Stroke","Cerebrovascular Disease",[33,132,133,134,135,136,137,138,139,140],"oral anticoagulant","blood pressure lowering","early intensive blood pressure lowering","care bundle","implementation study","reversal treatment","outcome","UW-mRS","Modified Rankin Scale","2026-05-20",{"date":143,"type":42},"2026-05-22",{"date":145,"type":42},"2025-01-07",{"date":147,"type":21},"2027-07",{"name":149,"class":49},"Region Skane",54,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":159,"studyType":23,"phases":4,"briefSummary":162,"conditions":163,"keywords":171,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":50},"100613980","characterization-of-extracellular-vesicles-from-the-cord-blood-of-extremely-preterm-new-borns-and-their-correlation-with-severe-morbidity-and-mortality-100613980","NCT07273643","Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality","VEEP","Inclusion Criteria:\n\n* Mother over 18 years old, able to speak and understand French\n* Newborn less than 28 weeks of gestation, born and hospitalized at Montpellier University Hospital\n* Umbilical cord venous blood collected immediately after birth (from the segment between the cord clamp and the placenta), with a volume of 10 ml (which can be reduced to 3 ml if collection is difficult) into an EDTA tube.\n* Parental non-opposition to the study obtained before sample collection\n\nExclusion Criteria:\n\n* Stillborn infant\n* Handling failure: failure to collect the sample or start the first centrifugation more than 3 hours after birth\n* General regulatory criteria: failure to obtain parental non-opposition, lack of social security coverage, individuals under legal guardianship, or participation in another ongoing research study with an active exclusion period","0 Days","3 Months",{"count":161,"type":21},30,"This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation. EVs are tiny particles released by cells that carry important information about the body's condition. In extremely premature infants, blood vessels may not function properly, leading to serious health problems such as bleeding in the brain, lung injury, or severe infections.\n\nResearchers believe that analyzing EVs in the umbilical cord blood of these infants may help predict which babies are at higher risk of developing these complications. By studying the size, number, and type of EVs, the team hopes to identify early markers that can guide doctors in providing better care.\n\nThe study will collect cord blood from 30 eligible infants born at the CHU of Montpellier. Blood samples will be processed to isolate platelet-poor plasma, which contains EVs. This plasma will be stored in a biobank, allowing future research on EVs and their role in extreme prematurity. EVs will then be analyzed in the laboratory to assess their characteristics and any links to severe health issues.\n\nThe findings from this study could improve understanding of circulatory problems in extremely premature infants, help identify early predictors of severe complications, and inform better monitoring and treatment strategies. The creation of a plasma biobank also provides a valuable resource for future research to enhance care and outcomes for this vulnerable population.",[28,164,165,166,167,168,169,170],"Pulmonary Hemorrhage","Death","ELGAN (22-28SA)","Bronchopulmonary Dysplasia (BPD)","Shock","Extracellular Vesicles","Enterocolitis, Necrotizing",[172,173,174,175,176,177,67],"ELGAN","Extremely Low Gestational Age Newborn (ELGAN)","Extracellular vesicles","EVs","Intraventricular hemorrage","Pulmonary hemorrhage","2026-02-19",{"date":180,"type":42},"2026-02-23",{"date":182,"type":42},"2026-01-13",{"date":184,"type":21},"2027-10-13",{"name":186,"class":49},"University Hospital, Montpellier",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":62,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100555342","lumbar-drainage-of-intraventricular-hemorrhage-100555342","NCT06510842","Lumbar Drainage of Intraventricular Hemorrhage","Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial","DRAIN IVH","Inclusion Criteria:\n\n* ICH with IVH (with hemorrhage in the 3rd and\u002For 4rth ventricle) with the need for EVD placement due to acute hydrocephalus\n* Age ≥ 18 y\n* Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well\n\nExclusion Criteria:\n\n* Premorbid mRS score \\> 2\n* Pregnancy\n* Life expectancy \\\u003C6 months\n* Patient\u002Ffamily\u002Fcaregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures\u002Fdiscontinuation of life support measures.\n* Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.\n* Other clear contraindication for treatment with a lumbar drain",{"count":196,"type":21},354,[93],"Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.",[28,98,99],"2026-01-26",{"date":202,"type":42},"2026-01-28",{"date":204,"type":42},"2025-01-16",{"date":206,"type":21},"2029-07",{"name":208,"class":49},"University Hospital Heidelberg",12,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":62,"phases":220,"briefSummary":221,"conditions":222,"keywords":226,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":50},"100608723","rainbow-ich-trial-of-ai-guided-minimally-invasive-neurosurgery-for-ich-100608723","NCT07205263","RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH","A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)","RAINBOW-ICH","Umbrella Trial Inclusion Criteria:\n\n1. Age ≥18 years；\n2. Clinical diagnosis of spontaneous hemorrhagic stroke；\n\nUmbrella Trial Exclusion Criteria:\n\n1\\. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage；\n\nEach substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.",{"count":219,"type":21},1000,[93],"Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. To address this gap, the RAINBOW-ICH trial has been designed as a nationwide, multicenter, randomized umbrella trial evaluating the efficacy and safety of AI-assisted, robotic-guided minimally invasive neurosurgery compared with conventional strategies across major ICH subtypes.\n\nUnder a single master protocol, RAINBOW-ICH incorporates multiple parallel randomized controlled substudies, each targeting a distinct ICH population-large basal ganglia hemorrhage, moderate basal ganglia hemorrhage, intraventricular hemorrhage, and brainstem hemorrhage. This umbrella design allows efficient use of resources while generating high-quality evidence tailored to the specific needs of different ICH subgroups, thereby supporting a more patient-centered approach to care.",[223,28,224,225],"Basal Ganglia Hemorrhage","Brainstem Stroke","Intracranial Hemorrhage, Spontaneous",[227,228,224,229,223,230],"Umbrella Trial","Intraventricular hemorrhage","Robotic-guided","Minimally invasive surgery","2026-01-06",{"date":233,"type":42},"2026-01-08",{"date":235,"type":42},"2025-09-30",{"date":237,"type":21},"2027-12",{"name":239,"class":49},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":62,"phases":251,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":5},"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","12 Hours",{"count":250,"type":21},500,[64],"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.",[254,28,255],"Extreme Prematurity","Morbidity;Newborn",[257,258,259,260],"extremely preterm","severe intraventricular hemorrhage","mortality","prophylactic indomethacin","2025-08-26",{"date":263,"type":42},"2025-09-03",{"date":265,"type":21},"2025-11-01",{"date":267,"type":21},"2031-03-31",{"name":269,"class":49},"University of British Columbia",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":62,"phases":282,"briefSummary":283,"conditions":284,"keywords":287,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":50},"100504495","optimization-of-saturation-targets-and-resuscitation-trial-optistart-100504495","NCT05849077","Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)","Optimization of Saturation Targets And Resuscitation (OptiSTART): Multicenter Randomized Controlled Trial","OptiSTART","Inclusion Criteria:\n\n-Neonates with OB gestational age 22-30 weeks\n\nExclusion Criteria:\n\n* Prenatally diagnosed cyanotic congenital heart disease\n* Prenatally diagnosed congenital diaphragmatic hernia\n* Parents request no resuscitation\n* If preductal saturations can not be measured by 3 minutes after pulse oximeter sensor is applied to the newborn","0 Minutes","10 Minutes",{"count":281,"type":21},700,[93],"This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term morbidities? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (≤ 30%) inspired O2 concentration (FiO2) and subsequent titration to achieve a specified target SpO2 range. These SpO2 targets are based on approximated 50th percentile SpO2 (Sat50) observed in healthy term infants. However, the optimal SpO2 targets remain undefined in the preterm infants. Recent data suggest that the current SpO2 targets (Sat50) may be too low. The investigators plan to conduct a multicenter RCT of Sat75 versus Sat50 powered for survival without BPD. The investigators will randomize 700 infants, 23 0\u002F7- 30 6\u002F7 weeks' GA, to 75th percentile SpO2 goals (Sat75, Intervention) or 50th percentile SpO2 goals (Sat50, control). Except for the SpO2 targets, all resuscitations will follow NRP guidelines including an initial FiO2 of 0.3. In Aim 1, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without lung disease (BPD). In addition, the investigators will compare the rates of other major morbidities such as IVH. In Aim 2, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without neurodevelopmental impairment at 2 years of age. In Aim 3, the investigators will determine whether targeting Sat75 compared to Sat50 decreases oxidative stress.",[285,67,28,286],"Premature Infants","Neurodevelopmental Outcomes",[288,289],"neonatal resuscitation","oxygen","2025-07-30",{"date":292,"type":42},"2025-08-05",{"date":294,"type":42},"2024-02-26",{"date":296,"type":21},"2029-04-01",{"name":298,"class":49},"University of Texas Southwestern Medical Center",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":62,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},"100482917","effects-of-a-physical-therapy-intervention-on-motor-delay-in-infants-admitted-to-a-neonatal-intensive-care-unit-100482917","NCT05568264","Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit","Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial","Inclusion Criteria:\n\nNICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:\n\n* BW \\\u003C1500 grams\n\nOR\n\n* Disorders of the central nervous system\n\n  * Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)\n\n    * HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled\n    * includes \"at risk for HIE\" with 10-minute Apgar \\\u003C7 plus pH\\\u003C7.15 or base deficit \\>\u002F=12.\n  * Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)\n  * Cramped synchronous movements at term PMA\n\nOR\n\n* Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \\\u003C32 weeks of gestation.\n\nAND\n\n* Medically stable AND able to start intervention between 34-48 weeks PMA.\n\nExclusion Criteria:\n\n(related to inability to complete intervention, sensor placement, or clinic assessments)\n\n* open wounds, skin condition precluding sensor placement\n* immune deficiencies requiring protective isolation\n* limb reduction defects\n* followed primarily in another clinic (including but not limited to meningomyelocele and related conditions\u002Ftrisomy 21)\n* bleeding disorders or ongoing need for anticoagulation\n* palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)\n* known visual impairment at the time of enrollment\n* DCFS custody\n* no English-speaking caregivers\n* any other condition that would preclude participation in the study, as determined by the PI\n* previously enrolled in competing randomized trial with developmental outcome variables\n\nEach child's enrollment in the study will be approved by the child's neonatologist.","33 Weeks","48 Weeks",{"count":309,"type":21},222,[93],"Study Aims\n\nPilot study: Due to the large recruitment goal and length of the project, the study team\u002FPIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis.\n\nAim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age.\n\nThe investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \\[an 8-point difference is considered a clinically meaningful difference\\]\n\nAim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay.\n\nThe Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age.\n\nAim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being.\n\nThe invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).",[313,314,28,315,67],"Motor Delay","Premature Birth","Hypoxic-Ischemic Encephalopathy","2025-05-19",{"date":318,"type":42},"2025-05-21",{"date":320,"type":42},"2022-10-01",{"date":322,"type":21},"2026-12-31",{"name":324,"class":49},"Shirley Ryan AbilityLab",3,{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":62,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":50},"100489191","affect-study-for-patients-with-intraventricular-hemorrhage-subarachnoid-hemorrhage-subdural-hematoma-and-ventriculitis-100489191","NCT05649904","AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis","Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection","AFFECT","Inclusion Criteria:\n\n1. Age ≥18 years of age\n2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis\n3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis\n4. Signed informed consent obtained by subject or Legally Authorized Representative\n\nExclusion Criteria:\n\n1. Subject has fixed and dilated pupils\n2. Pregnant women\n3. Presence of Moyamoya\n4. History or presence of clotting disorder.\n5. Platelet count less than 100,000, INR greater than 1.4",{"count":335,"type":21},240,[93],"The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).\n\nSubjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.",[28,27,339,340],"Subdural Hematoma","Ventriculitis","2025-03-26",{"date":343,"type":42},"2025-04-01",{"date":345,"type":42},"2023-02-07",{"date":347,"type":21},"2026-01",{"name":349,"class":49},"Ohio State University",{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":62,"phases":360,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":50},"100578720","phase-1-rhtnk-tpa-thrombolytic-removal-of-intraventricular-hemorrhage-100578720","NCT06814964","rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage","A Phase I Pilot Clinical Trial of Dose Escalation With Stereotactic-Guided Intraventricular Thrombolysis Using Tenecteplase (rhTNK-tPA) for Intraventricular Hemorrhage.","Inclusion Criteria:\n\n1. Age 18-80 years.\n2. Symptom onset within 24 hours prior to diagnostic CT scan. Patients with unknown onset time should be excluded. For patients with symptoms occurring during sleep, the time of symptom onset should be considered as the last time the patient was awake and asymptomatic.\n3. Spontaneous intracerebral hemorrhage (ICH) ≤ 30 ml，with intraventricular hemorrhage (IVH) \\>20 ml obstructing the third and\u002For fourth ventricles.\n4. All patients must have an external ventricular drain (EVD) placed prior to enrollment: The EVD should be accurately positioned into the largest cerebrospinal fluid (CSF) pool or the least bloody site in the lateral ventricle using robotic stereotactic guidance.\n5. A stability CT scan performed ≥ 6 hours after EVD placement must confirm ICH clot stability: The ICH volume change should be ≤ 5 ml compared to the previous CT scan. If the stability CT scan shows a difference \\> 5 ml, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a hematoma enlargement ≤ 5 ml and the ICH volume remains ≤ 35 ml, the patient is eligible.\n6. IVH clot stability: The width of the lateral ventricle most affected by the clot must not increase by \\> 2 mm. If the stability CT scan shows a difference \\> 2 mm, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a change ≤ 2 mm, the patient is eligible.\n7. Catheter tract bleeding on the stability CT scan must be ≤ 5 ml. If any CT slice shows catheter tract bleeding \\> 5 ml, a repeat stability CT scan should be performed ≥ 12 hours later. Stability CT scans may be repeated every 12 hours within 72 hours of the diagnostic CT scan. If two consecutive CT scans show a change ≤ 5 ml and the total hematoma volume along the tract is ≤ 10 ml, the patient is eligible.\n8. On the stability CT scan, the third and\u002For fourth ventricles must be occluded with blood.\n9. Primary IVH (ICH = 0) is eligible.\n10. Sustained systolic blood pressure (SBP) \\\u003C 180 mmHg for at least 6 hours prior to enrollment. (Patients do not need to meet the SBP criteria throughout the screening period, but vital signs should remain stable during the enrollment window).\n11. No intraventricular thrombolytic treatment within 12 hours of symptom onset.\n12. Enrollment must be completed within 72 hours of the diagnostic CT scan. (The 72-hour limit may be extended with PI approval for reasons such as hematoma stability, INR stability, or other valid justifications).\n13. Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.\n\nExclusion Criteria:\n\n1. Hemorrhage caused by aneurysms, arteriovenous malformations (AVM), tumors, or other identifiable causes. If the cause of ICH is unknown, CTA, DSA, or other definitive imaging must be performed during screening to rule out these causes. If imaging is negative, the patient is eligible.\n2. Presence of choroid plexus vascular malformation or Moyamoya disease.\n3. Hypercoagulable state or coagulopathy. Patients requiring long-term anticoagulation are excluded. Reversal of anticoagulation is permitted if long-term anticoagulation is not required.\n4. Use of anticoagulants (e.g., dabigatran, apixaban, rivaroxaban) or antiplatelet agents (e.g., tirofiban, ticagrelor, cilostazol, clopidogrel) within one week prior to symptom onset (aspirin is allowed).\n5. Platelet count \\\u003C 100,000 or INR \\> 1.4.\n6. Pregnancy (positive serum or urine pregnancy test).\n7. Infratentorial hemorrhage.\n8. Thalamic hemorrhage with significant midbrain extension, third nerve palsy, or dilated and non-reactive pupils. Other supranuclear gaze abnormalities are not excluded. Posterior fossa or cerebellar hemorrhages are excluded.\n9. Subarachnoid hemorrhage (SAH) or any atypical hematoma location or appearance on diagnostic CT scan. Angiography (CTA, DSA, or MRA\u002FMRI) must be performed to rule out other causes. If no source of bleeding is identified, the patient is eligible. Cortical SAH secondary to clot lysis is eligible.\n10. Unstable ICH\u002FIVH with ongoing hematoma enlargement.\n11. Indications for craniotomy: ① Progressive decline in consciousness; ② Signs of brain herniation; ③ Hematoma located \\\u003C 1 cm from the cortical surface.\n12. Ongoing internal bleeding involving retroperitoneal, gastrointestinal, genitourinary, or respiratory tracts. Patients with prior bleeding that is clinically stable for ≥ 12 hours and without coagulopathy or bleeding disorders are eligible.\n13. Multifocal superficial bleeding at multiple vascular puncture or access sites (e.g., venipuncture, arterial puncture) or recent surgical sites.\n14. Any condition that, in the investigator's opinion, poses a significant risk to the patient or makes the patient unsuitable for the study.\n15. Planned or concurrent participation in another interventional clinical trial. Participation in observational, natural history, or epidemiological studies without intervention is allowed.\n16. Inability to obtain informed consent from the patient or legal representative.","80 Years",{"count":359,"type":21},18,[361],"PHASE1","The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement.",[28],[365,366,367],"intraventricular hemorrhage","Stereotactic puncture therapy","rhTNK-tPA","2025-02-25",{"date":370,"type":42},"2025-02-27",{"date":372,"type":21},"2025-03-01",{"date":374,"type":21},"2025-06-01",{"name":376,"class":49},"Beijing Tiantan Hospital",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":62,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":50},"100448403","active-removal-of-intracerebral-hematoma-via-active-irrigation-100448403","NCT05118997","Active Removal of IntraCerebral Hematoma Via Active Irrigation","Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System","ARCH","Inclusion Criteria:\n\n1. Age \\>18 years of age\n2. Need of EVD\n3. Active treatment\n4. Signed informed consent obtained\n\n   a. Based on institutional and country laws\n5. Spontaneous ICH with maximum 30 square cm's\n6. If needed, normal coagulation profile (PT, PTT, platelet count)\n7. Treatment within 72 hours of ictus\n8. Ability to administer 2.0 mg of tPA per day for 3 days\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. No need of EVD\n3. Patient has fixed and dilated pupils\n4. Coagulopathy uncorrectable\n5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement)\n6. Pregnant women",{"count":386,"type":21},60,[93],"Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.",[96,28],[391,96,28],"Hemorrhage","2024-07-30",{"date":394,"type":42},"2024-08-01",{"date":396,"type":42},"2021-10-25",{"date":398,"type":21},"2025-09",{"name":400,"class":79},"IRRAS",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":411,"conditions":412,"keywords":415,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":50},"100551955","prediction-of-undesired-obstruction-in-external-ventricular-drains-100551955","NCT06466811","Prediction of Undesired Obstruction in External Ventricular Drains.","Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain: Development of a Score Based on the Extent of Intra-ventricular Hemorrhage. A Single-Center, Prospective Observational Study.","EVD-OBS","Inclusion Criteria :\n\nPatient older than 18 years old,\n\n* admitted to the ICU,\n* with first EVD inserted for less than 12 hours,\n* and brain imaging (CT or MRI) available in the timespan \"24 hours before to 24 hours after\" the EVD insertion.\n\nExclusion Criteria :\n\n* EVD intentionally occluded immediately after its insertion,\n* purulent cerebrospinal fluid\n* Pregnant or breast-feeding patient\n* Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment within the 12 hours\n* Patient with no health insurance\n* Patient under guardianship",{"count":410,"type":21},640,"Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated.\n\nConsequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.",[413,28,414],"Intensive Care Unit","External Ventricular Drain",[416,417,418,419,228,420],"Intensive care unit","External ventricular drain","Neuromeningeal infection","Obstruction","Functional outcome","2024-07-11",{"date":423,"type":42},"2024-07-12",{"date":425,"type":42},"2024-07-04",{"date":427,"type":21},"2026-12-01",{"name":429,"class":49},"Nantes University Hospital",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":440,"conditions":441,"keywords":447,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":455,"locationsCount":4},"100519559","pufas-in-preterm-infants-100519559","NCT06045130","PUFAs in Preterm Infants","Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis","PIPI","Inclusion Criteria:\n\nInfants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.\n\n\\-\n\nExclusion Criteria:\n\nInfants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.\n\n\\-",{"count":439,"type":21},600,"The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.",[442,28,443,444,445,446],"Necrotizing Enterocolitis","BPD - Bronchopulmonary Dysplasia","Sepsis","Periventricular Leukomalacia","Patent Ductus Arteriosus",[448],"PUFAs","2023-09-13",{"date":451,"type":42},"2023-09-21",{"date":451,"type":21},{"date":454,"type":21},"2026-08-31",{"name":456,"class":49},"The First Hospital of Jilin University"]