[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intraventricular-hemorrhage-of-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intraventricular-hemorrhage-of-prematurity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,70,97,126],{"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":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100486727","phase-1-safety-of-erythropoietin-and-melatonin-for-very-preterm-infants-with-intraventricular-hemorrhage-100486727",false,"NCT05617833","Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage","Safety of Combined Therapy With Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage (SCEMPI)","SCEMPI","Inclusion Criteria:\n\n* Neonatal intensive care unit (NICU) inpatients born at \\>22 and \\\u003C32 weeks gestation (born after 22w-6\u002F7 and before or on 31-6\u002F7 week GA)\n* IVH or moderate\u002Fsevere white matter injury within the first 21 days from birth\n* Infants born prior to 30 weeks GA may enroll until DOL 30. Infants born after 30 weeks may enroll until DOL 21. Treatment must be started by 33+0.\n* Approval of the primary neonatologist\n* Appropriate caregiver to provide informed consent\n* Is not known to meet or suspected of meeting any of the exclusion criteria (below).\n\nExclusion Criteria:\n\n* Participation in another pharmacological intervention trial that involves multiple doses of a medication that may interact with EPO+MLT. Examples of exemptions would include single dose administration for pharmacokinetic studies of an antibiotic, a single or few doses of a new surfactant, or a single intervention to reduce pain.\n* Is on jet ventilator or has not been off jet ventilator for at least 72 hours\n* Has been diagnosed with or is suspected of having a congenital anomaly or genetic disorder associated with brain malformation or life expectancy \\\u003C40 weeks post menstrual age (PMA). These include but are not limited to TORCH infections associated with radiographic evidence of substantial brain injury, trisomy 13, coarctation of the aorta, and severe liver failure. TORCH infections not associated with radiographic evidence of brain malformation or treatment for presumed TORCH infection are not exclusionary.\n* Is within 3 days of starting treatment for a severe clinical condition which is potentially associated with a life expectancy \\\u003C3 days. These include but are not limited to disseminated intravascular coagulation (DIC)\u002Fsevere hematologic crisis, severe sepsis, Hypoxic-ischemic encephalopathy (HIE), severe brain injury\n* Other clinical conditions including:\n\nHydrops fetalis Hypertension for age requiring sustained medication Polycythemia (hematocrit \\>65%)\n\n\\- No caregiver to provide consent\n\nThe clinical condition of potential candidates will be monitored throughout the eligibility period to ensure the participant's continued candidacy for participating in the trial.","ALL","12 Hours","2 Months",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious neurologically are white matter injury (WMI), intraventricular hemorrhage (IVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH). Currently, the only treatment for PHH is surgery, most commonly with shunts that are prone to malfunction across the lifespan. Preclinical data show that melatonin (MLT) and erythropoietin (EPO), when administered in a sustained dosing regimen, may promote neuro-repair, including the progression from early postnatal IVH to subsequent PHH. The investigators will perform a Phase I, single institution, randomized, double-blind trial for very preterm infants with IVH and WMI to define a safe combination dose of MLT and EPO. A maximum of 60 very preterm neonates with IVH and\u002For moderate to severe WMI will be enrolled, treated through 33w6\u002F7d, and followed to 37w6\u002F7d. Neonates will be randomized 3:1 between MLT+EPO and placebo, with all receiving standard of care. The primary endpoint is a composite serious adverse event (SAE)\u002Fdose limiting toxicity (DLT). The investigators hypothesize that the MLT+EPO SAE\u002FDLT rate will not be higher than the placebo rate. Secondary outcomes will be rate of co-morbidities of preterm birth. Exploratory data, collected to guide design of future clinical trials for efficacy, will include serial neuro-imaging metrics acquired from clinical images, serial neonatal neurodevelopmental examinations, serum and urine MLT and EPO levels, liquid and gut microbiome biomarkers. Successful implementation of this initial safety trial will provide essential data to guide the next stage of clinical trials to test if sustained MLT+EPO treatment can reduce neurological deficits, including the need for surgical intervention and the lifelong burden of shunted hydrocephalus.",[28],"Intraventricular Hemorrhage of Prematurity",[15,30,31,32,33],"Erythropoietin","Melatonin","preterm infants","Intraventricular Hemorrhage","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2024-04-30",{"date":42,"type":22},"2027-09",{"name":44,"class":45},"Johns Hopkins University","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100608192","outcome-of-intraventricular-hemorrhage-in-preterm-infants-100608192","NCT07198360","Outcome of Intraventricular Hemorrhage in Preterm Infants","Incidence, Risk Factors, and Outcomes of Intraventricular Hemorrhage in Preterm Infants Admitted to the NICU","Inclusion Criteria:\n\n* Preterm neonates \\\u003C 34 weeks of gestation\n* Birth weight \\\u003C 1500g\n* Admitted to NICU within 24 hours of birth\n\nExclusion Criteria:\n\n* Major congenital malformations (especially CNS anomalies)\n* Severe perinatal asphyxia\n* Neonates with congenital infections (TORCH)","28 Days",{"count":56,"type":22},300,"OBSERVATIONAL","To determine the incidence and grading of IVH among preterm neonates in the NICU.\n\n* To identify maternal and neonatal risk factors associated with IVH.\n* To assess short-term outcomes (mortality, Hydrocephalus, need for neurosurgical intervention, seizures, length of Hospital stay).",[28],"NOT_YET_RECRUITING","2025-09-21",{"date":63,"type":38},"2025-09-30",{"date":65,"type":22},"2025-09",{"date":67,"type":22},"2026-09",{"name":69,"class":45},"Assiut University",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":17,"minAge":4,"maxAge":54,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100605015","research-on-prevention-early-detection-and-clinical-evaluation-of-intracranial-hemorrhage-in-preterm-infants-100605015","NCT07157020","Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants","A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants","ROPEDACEOIHIPI","Inclusion Criteria:\n\n* Gestational age: 23+0 weeks to 36+6 weeks;\n* Post-hemorrhagic hydrocephalus is confirmed by cranial ultrasound or other cranial imaging examinations.\n* No cerebrospinal fluid drainage treatment was received before enrollment.\n\nExclusion Criteria:\n\n* Excluding secondary IVH, including but not limited to congenital malformations, vitamin K1 deficiency, abnormal coagulation function, etc.\n* Excluding hydrocephalus caused by other reasons, including but not limited to infection, congenital malformations, intracranial space-occupying lesions, etc.\n* Treatment before diagnosis of hydrocephalus after intraventricular hemorrhage or suspected presence of central nervous system infection.",true,{"count":56,"type":22},[81],"NA","1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a scientific basis for optimizing clinical intervention.\n2. Apply ultrasound radiomics technology to explore and formulate new standards for imaging diagnosis and treatment; By integrating metabolomics, ultrasound radiomics and clinical data, high-risk individuals for intracranial hemorrhage and their relationship with prognosis can be identified early.\n3. To explore whether advancing the indication for surgical intervention of hydrocephalus in preterm infants after hemorrhage from ventricular index P97+4mm to P97 and whether repeated lumbar puncture and drainage can improve their prognosis, with the aim of clarifying the optimal timing for intervention of hydrocephalus in preterm infants after hemorrhage and optimizing the treatment methods.",[28],[28,85,86,87],"prevention","early detection","clinical evaluation","2025-09-03",{"date":90,"type":38},"2025-09-05",{"date":92,"type":22},"2025-09-01",{"date":94,"type":22},"2026-12-31",{"name":96,"class":45},"Second Affiliated Hospital of Wenzhou Medical University",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":46},"100577355","light-therapy-device-for-neonatal-intraventricular-hemorrhage-grade-3-and-4-100577355","NCT06797219","Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4","EFIL","Inclusion Criteria:\n\n* neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.\n\nExclusion Criteria:\n\n* neonates without IVH grade 3\u002F4 or older than 1 month.","0 Days","1 Month",{"count":107,"type":22},24,[81],"The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\\' experience with the study intervention. A complete list of objectives and aims are listed under \"Objectives\". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW\u002Fcm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.",[28,111],"Hydrocephalus",[113,114,115,116],"low level laser therapy","neonate","developmental milestones","intraventricular hemorrhage","2025-07-16",{"date":119,"type":38},"2025-07-22",{"date":121,"type":38},"2025-02-25",{"date":123,"type":22},"2028-07-31",{"name":125,"class":45},"Rutgers, The State University of New Jersey",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":146,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100537672","physiologically-based-cord-clamping-to-improve-neonatal-outcomes-in-moderate-and-late-preterm-newborns-100537672","NCT06280872","Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns","Prospective Unblinded Randomized Controlled Study Assessing the Physiologically Based Cord Clamping on Ventilation Duration in Moderate and Late Preterm","PhyCordPrem","Inclusion Criteria:\n\nPregnant women followed-up in Brugmann University Hospital will be eligible to participate if:\n\n* The delivery takes place between 32 0\u002F7 and 36 6\u002F7 weeks of gestation\n* They carry singletons\n\nExclusion Criteria:\n\n* Fetal anomalies including congenital malformations, anemia, and growth restriction with abnormal Dopplers.\n* Abnormal placentation such as placenta previa.\n* Signs of fetal distress necessitating an emergency cesarean section.\n* Maternal health issue including severe anemia (defined as hemoglobin level \\\u003C 7 g\u002FdL), preeclampsia, and bleeding disorders.\n* Maternal refusal of the use of blood products.\n* General anesthesia for cesarian section.\n* Planned cord blood banking.\n* Total language barrier without possibility of translation","32 Weeks","36 Weeks",{"count":137,"type":22},180,[81],"Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way.\n\nA baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.",[141,142,143,28,144,145],"Premature Birth","Respiratory Distress Syndrome in Premature Infant","Sepsis","Bronchodysplasia","Jaundice",[147,148,149,150],"Moderate and late preterm newborn","Neonatal respiratory morbidity","Physiological based-cord clamping","Mother-infant bonding","2024-03-01",{"date":153,"type":38},"2024-03-05",{"date":155,"type":38},"2024-02-19",{"date":157,"type":22},"2026-07",{"name":159,"class":45},"Queen Fabiola Children's University Hospital"]