[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"retinopathy-of-prematurity-rop\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:retinopathy-of-prematurity-rop":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,66,90,119,143,185,219,246,272,293,319,346],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100601587","phase-1-fentanyl-intranasal-for-retinopathy-of-prematurity-screening-in-preterm-infants-100601587",false,"NCT07112430","Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants","Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial","FIREFLY","Inclusion Criteria\n\n* Preterm infants born ≤31 weeks gestational age and\u002For with birth weight \\\u003C1250 g\n* Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care\n* Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support\n* Written informed consent obtained from a parent or legally authorized representative\n\nExclusion Criteria\n\n* Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration\n* Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative\u002Fanalgesic medications within 24 hours prior to the ROP examination\n* Known hypersensitivity or prior adverse reaction to fentanyl","ALL",{"count":19,"type":20},58,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening.\n\nParticipants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.",[27,28,29,30,31,32,33,34,35],"Neonatal Pain","Retinopathy of Prematurity (ROP)","Pain Management","Infant, Premature","Fentanyl","Infant, Newborn","Neonatal Intensive Care Units","Analgesia","Intranasal Drug Administration",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"intranasal fentanyl","fentanyl","neonatal analgesia","procedural pain","ROP screening","Retinopathy of Prematurity","Preterm infants","Premature infants","infant pain","Non-invasive analgesia","Opioid analgesia","Intranasal drug delivery","Neonatal intensive care","NICU","Pain management in neonates","Infant procedural sedation","NOT_YET_RECRUITING","2026-06-26",{"date":56,"type":57},"2026-06-30","ACTUAL",{"date":59,"type":20},"2026-09-09",{"date":61,"type":20},"2028-06-01",{"name":63,"class":64},"Marsha Campbell-Yeo","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":17,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100641803","hbm-based-education-for-retinopathy-of-prematurity-screening-in-parents-of-premature-infants-100641803","NCT07661654","HBM-Based Education for Retinopathy of Prematurity Screening in Parents of Premature Infants","Impact of Health Belief Model-Based Education on Retinopathy of Prematurity Screening Knowledge and Practices in Parents of Premature Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Mother or father of a premature infant attending Retinopathy of Prematurity (ROP) clinic\n* Parent aged 18 years or older\n* Parent of a premature infant who was admitted to the Neonatal Intensive Care Unit (NICU)\n* Able to understand English or Urdu\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Parents with disability or cognitive impairment affecting participation\n* Uncooperative participants\n* Parents unwilling or unable to provide informed consent",true,"18 Years",{"count":76,"type":20},99,[78],"NA","The goal of this clinical trial is to learn whether Health Belief Model (HBM)-based educational interventions can improve knowledge and practices related to Retinopathy of Prematurity (ROP) screening among parents of premature infants attending ROP clinics in Karachi, Pakistan. The main questions it aims to answer are:\n\n* Do HBM-based educational interventions improve parents' knowledge about Retinopathy of Prematurity screening?\n* Do HBM-based educational interventions improve parents' screening-related practices and follow-up for Retinopathy of Prematurity?\n\nResearchers will compare different educational approaches, including video-based education, audio-based education, and standard educational material, to see which method is more effective in improving parental understanding and practices regarding ROP screening.\n\nParticipants will:\n\n* Complete a questionnaire assessing their knowledge and practices related to Retinopathy of Prematurity screening at baseline\n* Receive one of the following educational approaches: video message plus counselling and pamphlet, audio message plus counselling and pamphlet, or counselling and pamphlet only\n* Attend a follow-up visit approximately 2 weeks after the initial visit\n* Complete a follow-up questionnaire to assess changes in knowledge and practices related to Retinopathy of Prematurity screening",[28],"2026-06-16",{"date":83,"type":57},"2026-06-22",{"date":85,"type":20},"2026-07",{"date":87,"type":20},"2027-04",{"name":89,"class":64},"Aga Khan University",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"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":100,"type":20},338,[24],"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.",[104,105,106,28],"Bronchopulmonary Dysplasia","Chronic Lung Disease of Prematurity","Intraventricular Hemorrhage","RECRUITING","2026-06-10",{"date":110,"type":57},"2026-06-11",{"date":112,"type":57},"2019-05-09",{"date":114,"type":20},"2028-01-21",{"name":116,"class":117},"OHB Neonatology Ltd.","INDUSTRY",72,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":65},"100600112","phase-1-safety-pk-and-pd-of-flq-101-in-premature-neonates-100600112","NCT07093255","Safety, PK and PD of FLQ-101 in Premature Neonates","A Phase 1b, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of FLQ-101 in Premature Neonates at High Risk of Developing ROP","tROPhy-1","Inclusion Criteria:\n\n* Written consent is obtained from parent(s) or legal guardian.\n* Neonates born at 26 weeks +0 days and 27 weeks +6 days of gestation.\n* Male or female infants with a birth weight greater than or equal to 650 gm.\n\nExclusion Criteria:\n\n* Neonates with congenital malformation of the eye or any other ocular condition that may prevent or relevantly affect any of the assessments or procedures.\n* Neonates with serious congenital anomalies, severe congenital infection, and chromosomal abnormalities.\n* Neonates who are seriously ill and not expected to survive.\n* Neonates with heart disease, including cardiomyopathy, serious arrhythmias, and congenital heart disease. (Neonates with patent foramen ovale may be included in the study if clinically stable).\n* Neonates that are small for gestational age defined as having a weight \\\u003C10th percentile at birth based on the Fenton growth charts for gestational age and sex.\n* Neonates with history of or ongoing intraventricular hemorrhage (IVH) grades 2, 3 or 4. Neonates with IVH grade 1 may be included in the study at the discretion of the PI.\n* Neonates with any other medical conditions or clinically significant comorbidities or circumstances that in the opinion of the investigator may have a relevant impact on study participation or any of the study assessments or procedures.\n* Infants scheduled to participate in other interventional clinical trials while participating in the study and until reaching end of study.","4 Days","5 Days",{"count":130,"type":20},18,[23],"The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.",[28],"2026-04-16",{"date":136,"type":57},"2026-04-21",{"date":138,"type":57},"2026-04-03",{"date":140,"type":20},"2026-12-31",{"name":142,"class":117},"FELIQS INC.",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":165,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":65},"100631599","heterologous-cord-blood-derived-red-blood-cell-for-transfusion-in-extremely-preterm-infants-100631599","NCT07502781","Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants","Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants","Inclusion Criteria:\n\n* Signed informed consent obtained from parents or legal guardians.\n* Gestational age at birth \\\u003C 28 weeks or birth weight \\\u003C 1000 g.\n* Admission to one of the participating neonatal intensive care units (NICUs) in the Barcelona area.\n\nExclusion Criteria:\n\n* Prior red blood cell transfusion during the fetal or neonatal period.\n* Maternal-fetal immunization (e.g., isoimmunization).\n* Fetal hydrops.\n* Major congenital malformations.\n* Congenital infections.\n* Immediate need for blood before randomization (e.g., hemorrhagic shock, consumptive coagulopathy).\n* Participation in another clinical trial that could interfere with the primary outcome.","23 Weeks","28 Weeks",{"count":153,"type":20},176,[78],"Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red blood cell transfusions during their hospital stay.\n\nCurrently, transfusions are given using red blood cells donated by adults. An alternative option is to use red blood cells collected from umbilical cord blood, which may be more similar to a newborn's own blood. This approach has been used in some neonatal units with encouraging results and no reported safety concerns.\n\nThis study aims to determine whether transfusion with umbilical cord blood improves clinical outcomes and reduces potential side effects compared to standard adult donor blood transfusion in extremely preterm infants. We hypothesize that umbilical cord blood transfusion will be at least as safe as adult donor blood and may provide clinical benefits.\n\nAbout 115 extremely preterm infants admitted to neonatal units in Catalonia will participate. If parents agree, their baby will be randomly assigned to receive either compatible umbilical cord blood or compatible adult donor blood if a transfusion becomes necessary. Babies will only receive a transfusion if they clinically need one. If cord blood is not available at the time of transfusion, the baby will receive compatible adult donor blood regardless of the assigned group.\n\nTo evaluate the response to treatment, small blood samples will be collected at birth, at one month of life, and 24 hours after any transfusion. These samples are taken at the same times as routine blood tests, so participation does not require additional needle sticks. The amount of blood collected is minimal (about 0.2 mL per sample).\n\nIn addition, a painless and non-invasive sensor will be placed on the baby's head for 24 hours to measure oxygen delivery to the brain. Urine samples will also be collected before and after transfusion to help assess how oxygen reaches body tissues.\n\nParticipation will continue until the baby reaches 36 weeks of postmenstrual age or is discharged from the hospital, whichever comes first.",[157,158,159,160,161,162,28,163,164],"Extremely Premature Infant","Anemia Neonatal","Blood Transfusion","Umbilical Cord Blood","Fetal Hemoglobin","Bronchopulmonary Dysplasia (BPD)","Death; Neonatal","Intensive Care Units, Neonatal",[166,167,168,169,170,171,172,173,174,175],"Cord blood red blod cell transfusion","Umbilical cord blood transfusion","Extremely preterm infants","Neonatal anemia","Fetal hemoglobin","Adult donor red blood cells","Bronchopulmonary dysplasia","Retinopathy of prematurity","Oxygen delivery","Days requiring oxygen supplementation","2026-03-27",{"date":178,"type":57},"2026-03-31",{"date":180,"type":20},"2027-01",{"date":182,"type":20},"2029-12",{"name":184,"class":64},"Hospital Clinic of Barcelona",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":65},"100625829","retinopathy-of-prematurity---visual-function-and-retinal-structure-100625829","NCT07427719","Retinopathy of Prematurity - Visual Function and Retinal Structure","Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure","Inclusion criteria:\n\n* Patients treated for ROP with either laser or injection of A-VEGF.\n* Patients previously diagnosed with ROP but not treated for the condition.\n\nExclusion criteria:\n\n* Age below six years at date of examination.\n* A developmental level not compatible with performing the study examinations.\n* Patients born or treated outside Norway\n* Known ocular or systemic disease that can give structural or functional changes in the retina.","6 Years","20 Years",{"count":195,"type":20},140,"OBSERVATIONAL","Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.\n\nIn this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).",[28,199,200,201],"Prematurity Complications","Cerebral Visual Impairment","Visual Field Defect",[42,203,204,205,206,207,208,209],"Treatment","Laser","anti-vascular endothelial growth factor","Visual field defect","Cerebral visual impairment","Refractive errors","Prematurity","2026-02-16",{"date":212,"type":57},"2026-02-23",{"date":214,"type":20},"2026-04-01",{"date":216,"type":20},"2029-06-01",{"name":218,"class":64},"Oslo University Hospital",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":192,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":65},"100602472","the-correlation-between-red-cell-transfusion-and-complications-of-prematurity-100602472","NCT07123948","The Correlation Between Red Cell Transfusion and Complications of Prematurity","The Correlation Between Packed Red Blood Cell Transfusion and Early and Late Complications of Prematurity","Inclusion Criteria:\n\n* all children born as premature infants \\\u003C32. weeks of gestation in Clinical Hospital Centre Rijeka from June 2018. to December 2021. (and who will be on September 2025. six years old)\n* signed informed consent\n\nExclusion Criteria:\n\n* genetic syndromes, severe congenital anomalies","7 Years",{"count":228,"type":20},128,"The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity. The main questions it aims to answer are:\n\n* Do premature infants who receive blood transfusions within their first month of life have a higher risk of early prematurity complications, such as retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, and intraventricular haemorrhage?\n* Do premature infants who receive blood transfusions during their first month of life have worse neurological and neurodevelopmental outcomes than those who do not? The first part of the study is retrospective, using data collected from participants' histories. The second part is prospective, evaluating neurological and neurodevelopmental outcomes at the age of six years.",[28,162,231,232],"Enterocolitis, Necrotizing","Intraventricular Hemorrhage Neonatal",[234,235,236],"Infant, Premature;","Erythrocyte Transfusion","Neurodevelopmental Disorder","2025-08-12",{"date":239,"type":57},"2025-08-14",{"date":241,"type":20},"2025-09-01",{"date":243,"type":20},"2029-03-01",{"name":245,"class":64},"Clinical Hospital Center Rijeka",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":65},"100563159","point-of-care-ophthalmic-diagnostic-imaging-of-retinopathy-of-prematurity-100563159","NCT06612541","Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity","ROP Imaging","Inclusion Criteria:\n\n* Preterm male and female infants born at 24-34 weeks gestational age and weighing \\<1500g at birth\n\nExclusion Criteria:\n\n* Infants surgically treated for ROP\n* Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team","24 Weeks","34 Weeks",{"count":256,"type":20},90,"The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.",[28,259],"ROP Examination",[42,261,209,262],"ROP","OCT Imaging","2025-05-12",{"date":265,"type":57},"2025-05-15",{"date":267,"type":57},"2025-02-01",{"date":269,"type":20},"2030-02",{"name":271,"class":64},"Vanderbilt University Medical Center",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":292},"100571220","efficacy-and-safety-of-low-dose-conbercept-for-retinopathy-of-prematurity-therapy-100571220","NCT06717412","Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy","Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: A Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial","Inclusion Criteria:\n\n* Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age\n* Bilateral type 1 ROP with one of the following retinal findings in each eye\n* Zone I, stage 1+, 2+, 3+\u002F- disease, or\n* Zone II, stage 2+, 3+, disease, or\n* A-ROP\n\nExclusion Criteria:\n\n* Preterm infants with stage 4 or 5 ROP in one or both eyes\n* Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy\n* Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)\n* Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer\n* Have active ocular infection within 5 days before or on the day of first investigational treatment\n* Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes\n* Have any contraindication for intravitreal injection clearly stated in the instructions\n* Have any ocular structural abnormality that may affect efficacy assessments\n* Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function\n* Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments",{"count":280,"type":20},146,[78],"Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)",[28],"2025-04-01",{"date":286,"type":57},"2025-04-04",{"date":288,"type":57},"2024-11-29",{"date":140,"type":20},{"name":291,"class":64},"Wang Yusheng",3,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":65},"100572135","a-multicenter-and-prospective-study-of-screening-retinopathy-of-prematurity-in-china-100572135","NCT06729333","A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China","SChiROP","Inclusion Criteria:\n\nFrom December 2024 to May 2025, preterm infants (gestational age \\\u003C37 weeks) or low birth weight infants (birth weight \\\u003C2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.\n\nExclusion Criteria:\n\n1. Death before the first screening;\n2. Death or loss to follow-up before complete retinal vascularization;\n3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;\n4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;\n5. Poor systemic condition preventing fundus examination;\n6. History of ocular trauma or surgery (excluding treatments for ROP);\n7. Poor-quality fundus images;\n8. Other conditions deemed exclusionary by the investigators.",{"count":301,"type":20},5000,"The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.",[304,28,305],"Premature Birth of Newborn","Low Birthweight Infant",[307,308,309],"retinopathy of prematurity","incidence rate","screening","2024-12-06",{"date":312,"type":57},"2024-12-11",{"date":314,"type":20},"2024-12-15",{"date":316,"type":20},"2026-06-14",{"name":318,"class":64},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":73,"sex":17,"minAge":151,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":65},"100569427","the-effect-of-two-non-pharmacological-methods-on-pain-during-retinopathy-examination-100569427","NCT06694103","The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination","The Effect of Reverse Kangaroo Care Position and ROP Position on Pain During Retinopathy Examination in Premature Infants","Inclusion Criteria:\n\n* Gestational age \\\u003C34 weeks,\n* Birth weight ≤ 2500 grams,\n* No painful interventions at least 1 hour before the ROP examination,\n* Fed at least 1 hour before the ROP examination,\n* Premature infants whose parents consented to participate in the study.\n\nExclusion Criteria:\n\n* Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.)\n* Any congenital anomaly (eye, neurological, etc.),\n* Have a diagnosed hearing problem,\n* A different painful procedure was performed at least one hour before the ROP examination,\n* Administration of an analgesic\u002Fsedative medication before the examination,\n* Premature infants whose parents did not consent to participate in the study.","33 Weeks",{"count":328,"type":20},84,[78],"The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain. The main questions it aims to answer are as follows:\n\n1. Is the reverse kangaroo care position effective in reducing the pain of premature infants during the ROP examination?\n2. Is the reverse kangaroo care position more effective in reducing the pain of premature infants compared to the ROP position during the ROP examination?\n\nResearchers will determine the effect of reverse kangaroo care position and ROP position applied during premature retinopathy examination in premature infants with a gestational age of less than 34 weeks on pain in infants.\n\n* The infants of parents who volunteer to participate in the study will be divided into two groups as Reverse Kangaroo Care Position group and ROP Position group according to randomization.\n* From the infants whose pupils are sufficiently mydriasis and are taken to the examination table, premature infants in the ROP Position group will be given ROP position together with the nurse and the parent.\n* Premature infants in the Reverse Kangaroo Care Position group will be given reverse kangaroo care position.\n* Video recording will be made during the given positions.\n* The effects of the applied positions on pain will be determined as a result of the measured parameters before, during and after the examination.",[28],[333,334,28,335,336],"Premature","Retinopathy Screening","Reverse Kangaroo Care Position","Pain","2024-11-16",{"date":339,"type":57},"2024-11-19",{"date":341,"type":57},"2024-02-19",{"date":343,"type":20},"2025-07-30",{"name":345,"class":64},"Sinem Basdemir",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":353,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":196,"phases":4,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":65},"100566002","long-term-ophthalmic-outcomes-in-ex-premature-infants-100566002","NCT06649513","Long-term Ophthalmic Outcomes in Ex-premature Infants","LTOO-XP","Inclusion Criteria:\n\n* Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.\n\nExclusion Criteria:\n\n* Subjects born after 2008,\n* Subject has passed away before the start of the study\n* Subject resides outside of the Netherlands\n* Subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.","16 Years",{"count":355,"type":20},210,"There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.",[28,358],"Premature Birth",[42,360,361,362,363],"Preterm birth","Visual acuity","Visual outcomes","Long term outcomes","2024-10-17",{"date":366,"type":57},"2024-10-18",{"date":368,"type":20},"2024-11-01",{"date":370,"type":20},"2030-11-01",{"name":372,"class":64},"Erasmus Medical Center"]