[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"retinopathy-of-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:retinopathy-of-prematurity":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,73,98,127,156,184,204,227,254],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100540339","an-observational-study-to-collect-data-on-how-aflibercept-eylea-given-using-a-paediatric-dosing-device-is-used-in-preterm-babies-with-retinopathy-of-prematurity-in-the-united-kingdom-uk-100540339",false,"NCT06315556","An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)","Drug Utilization Study for Eylea 40 mg\u002FmL Using the PICLEO Paediatric Dosing Device in Preterm Infants With Retinopathy of Prematurity in the UK","Inclusion Criteria:\n\n* Eligible infants within the NNRD include those who were:\n\n  * 1\\. Born during the study period, i.e. from Q4\u002F2023 following market introduction of Eylea PFS+PDD and 31st December 2026, and\n  * 2\\. Received care in a neonatal unit that contributes data to the NNRD and the unit has agreed to participate in the study, and\n  * 3\\. Diagnosed with ROP in any stage in at least one eye.\n\nExclusion Criteria:\n\n* Infants with missing data for gestational age at birth will be excluded.","ALL","1 Year",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied.\n\nROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth.\n\nAflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina.\n\nAflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner.\n\nSince there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown.\n\nThe main purpose of this study is to:\n\n* find the number of preterm babies who are treated with aflibercept using a PDD in the UK\n* inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP\n\nAn additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD.\n\nThe data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027.\n\nIn this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.",[24,25],"Retinopathy of Prematurity","Preterm Infants",[27],"ROP","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2024-03-05",{"date":36,"type":20},"2027-04-30",{"name":38,"class":39},"Bayer","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100438903","retinal-microanatomy-in-retinopathy-of-prematurity-babysteps2-100438903","NCT04995341","Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)","Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)","BabySTEPS2","Inclusion Criteria:\n\n* Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only\n* Parent\u002FLegal Guardian is able and willing to consent to study participation with follow up approximately between 4.5 and 5 years of age (consent available in Spanish\\* and English) (SA 1 only)\n* Parent\u002FLegal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only)\n* Infant\u002Fchild undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only)\n* Infant inborn or outborn at (SA 2 only):\n* Duke Hospital (Years 1, 2 and 3) with birth weight ≤1000 grams, and\u002For 20 0\u002F7 to 28\u002F 6\u002F7 (\\\u003C29 weeks) gestational age\n* Duke Hospital (Years 1, 2 and 3) at high risk to require treatment for ROP irrespective of birth weight and gestational age (e.g. pre-plus, severe ROP in zone 1, APROP, etc.)\n* Duke Regional Hospital (Years 4 and 5) that meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks)\n* Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only)\n\nExclusion Criteria:\n\n* Participant or Parent\u002FLegal Guardian unwilling or unable to provide consent\n* Adult participant or infant\u002Fchild has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract) (SA2 only)\n* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)",true,{"count":51,"type":20},236,"INTERVENTIONAL",[54],"NA","Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.",[24],[58,59,24,60,61],"Optical Coherence Tomography (OCT)","Optical Coherence Tomography Angiography (OCTA)","Neurodevelopment","Visual Acuity","2026-05-19",{"date":64,"type":32},"2026-05-22",{"date":66,"type":32},"2021-08-16",{"date":68,"type":20},"2027-03-31",{"name":70,"class":71},"Duke University","OTHER",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":52,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100292176","phase-2-oral-propranolol-for-prevention-of-threshold-retinopathy-of-prematurity-100292176","NCT03083431","Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity","RoProp","Inclusion criteria:\n\n* Preterm infant born before 28 week's gestation\n* Birth weight below 1250 g\n* At least 5 weeks of age (at randomisation)\n* PMA 310\u002F7 - 36 6\u002F7 weeks\n* Ophthalmoscopic evidence of incipient ROP (stage 1 or 2, with or without plus disease in any zone)\n* Written informed consent by parents or legal guardian, according to national requirements\n\nExclusion Criteria:\n\n* ROP stage ≥ 3, AP-ROP or suspected AP-ROP, or any other ROP requiring an intervention (study endpoint already reached).\n* Conditions that indicate open label propranolol such as: thyrotoxicosis, arterial hypertension or certain heart diseases (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome) etc.\n* Major congenital malformations or known chromosomal anomalies\n* Colobomas and other eye malformations\n* PHACE syndrome (posterior fossa anomalies, large infantile hemangiomas of the face, neck, and\u002For scalp, arterial lesions, cardiac abnormalities\u002Fcoarctation of the aorta, eye anomalies) (risk of cerebrovascular complications)\n* Very large hemangioma (risk of hyperkalemia), as judged by the attending physician\n* Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic clearance)\n* Chronic kidney impairment (serum creatinine \\> 1.3 mg\u002Fdl \\[115 μmol\u002FL\\])\n* Severe liver dysfunction (ALT (GPT) \\> 900 U\u002FL)\n* Known hypersensitivity to propranolol or any of the excipients (see 6.3.1.)\n* Prinzmetal's angina, Raynaud's phenomenon (severe peripheral arterial circulatory disturbance), or pheochromocytoma (contraindications for propranolol in adults, not occurring in newborn infants)\n* Any circumstances that make the investigator believe that participation in the study leads to exceptional medical or organizational problems for the patient\n* Conditions that prohibit propranolol therapy such as: Atrio-ventricular block grade 2 or 3 hypertrophic cardiomyopathy, sinoatrial block, uncontrolled heart failure or cardiogenic shock, bronchial asthma\n* Medication of the infant or the mother if breastfeeding with clonidine, reserpine, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists (contraindicated in preterm infants) or antiarrhythmic drugs including amiodarone, propafenone, lidocaine, digoxin\u002Fdigitoxin, quinidine, verapamil, diltiazem, bepridil (pharmacodynamic interaction)","5 Weeks","15 Weeks",{"count":83,"type":20},276,[85],"PHASE2","Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser surgery or injection of drugs into the eye balls, may prevent most but not all cases of permanent ROP-mediated blindness. Both types of treatment are associated with significant costs and side effects.\n\nAn orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.",[24],"2026-05-04",{"date":90,"type":32},"2026-05-07",{"date":92,"type":32},"2022-09-22",{"date":94,"type":20},"2029-12-31",{"name":96,"class":71},"University of Zurich",3,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":72},"100482133","imaging-retinal-vasculature-in-infant-eyes-100482133","NCT05558059","Imaging Retinal Vasculature in Infant Eyes","Elucidating Perifoveal Vasculature Development in Infants","Inclusion Criteria:\n\n* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent\u002FLegal guardian\n* Parent\u002FLegal Guardian is able and willing to consent to study participation for the infant\n* Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6\u002F7 weeks postmenstrual age at first visit\n\nExclusion Criteria:\n\n* Participant or Parent\u002FLegal Guardian unwilling or unable to provide consent\n* Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)\n* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)","2 Months",{"count":107,"type":20},16,"Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.",[24],[24,111,112,113,114,27,115,116,117,118],"Optical Coherence Tomography","Perifoveal vasculature","Vascular development","Macular edema","OCT","Prematurity","Optical Coherence Tomography Angiography","OCTA","2025-10-02",{"date":121,"type":32},"2025-10-06",{"date":123,"type":32},"2024-10-03",{"date":125,"type":20},"2027-08-31",{"name":70,"class":71},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":52,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":40},"100521312","phase-3-intranasal-dexmedetomidine-for-pain-management-during-screening-for-retinopathy-of-prematurity-100521312","NCT06067958","Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity","Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial","Inclusion Criteria:\n\n* Gestational age \\\u003C 31 weeks post-menstrual age, or birth weight \\\u003C 1500 grams\n* Informed consent signed by one of the parents\n\nExclusion Criteria:\n\n* Invasive ventilation at the time of the eye assessment\n* Multiple congenital anomalies\n* Chromosomal \u002F genetic anomalies\n* Infant received a sedative drug in last 5 days\n* Eye examination for reasons other than retinopathy of prematurity screening\n* Attending physician deemed the patient not stable enough","4 Weeks",{"count":136,"type":20},30,[138],"PHASE3","Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed \"retinopathy of prematurity\". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain.\n\nPurpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.\n\nThe main questions it aims to answer are:\n\n* Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).\n* Does dexmedetomidine cause more adverse effects than placebo.\n\nIn this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.",[24,141],"Dexmedetomidine",[24,141,143,144,145],"Pain","Analgesia","Premature Infant Pain Profile - Revised","2024-12-04",{"date":148,"type":32},"2024-12-06",{"date":150,"type":32},"2023-12-11",{"date":152,"type":20},"2025-12",{"name":154,"class":155},"Assaf-Harofeh Medical Center","OTHER_GOV",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":163,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":52,"phases":166,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":40},"100567801","impact-of-standardized-skin-to-skin-care-on-clinical-outcomes-in-infants-born--32-weeks-a-multicenter-study-100567801","NCT06672913","Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study","TR-SSCinNICU","Inclusion Criteria:\n\n* Infants born at gestational age ≤ 32 weeks\n\nExclusion Criteria:\n\n* Death before NICU discharge\n* Abdominal wall defects","1 Day",{"count":165,"type":20},120,[54],"This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical outcomes for preterm infants born ≤ 32 weeks of gestation.\n\n1. Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.\n2. Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.",[169,170,171,172,24],"Premature","Skin to Skin Contact","Breast Feeding","Necrotizing Enterocolitis",[169,174,171,172,24],"Skin to skin contact","2024-11-01",{"date":177,"type":32},"2024-11-04",{"date":179,"type":32},"2024-09-01",{"date":181,"type":20},"2025-06-01",{"name":183,"class":71},"Baskent University Ankara Hospital",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":40},"100536479","evaluation-of-the-frequency-risk-factors-and-outcomes-of-rop-in-infants-with-a-bw-1500-grs-or-ga-33-wks-in-turkey-100536479","NCT06265363","Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.","Evaluation of the Frequency of Retinopathy of Prematurity, Influencing Risk Factors, and Treatment Outcomes in Premature Infants With a Birth Weight >1500 Grams or Gestational Age ≥33 Weeks in Turkey.","TR-ROP-2","Inclusion Criteria:\n\n* Infants with BW \\>1500 g or ≥33 weeks' gestation who were determined to be at risk for ROP by the attending clinician and were screened for ROP.\n\nExclusion Criteria:\n\n* Neonates who died before the first ROP examination are excluded from the study.","28 Days",{"count":194,"type":20},1000,"The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \\>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated.",[24],"2024-10-31",{"date":175,"type":32},{"date":200,"type":32},"2023-08-01",{"date":202,"type":20},"2024-12-01",{"name":183,"class":71},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":210,"maxAge":211,"enrollmentInfo":4,"targetDuration":4,"studyType":52,"phases":212,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":40},"100083677","phase-2-antiangiogenic-therapy-with-bevacizumab-in-retinopathy-of-prematurity-structural-outcome-100083677","NCT00346814","Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome","Inclusion Criteria:\n\n* Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY\n\nExclusion Criteria:\n\n* PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER","1 Month","12 Months",[85,138],"Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity",[24],[216,217],"Retinopathy of prematurity","antiangiogenic therapy","2024-07-30",{"date":220,"type":32},"2024-07-31",{"date":222,"type":32},"2007-07",{"date":224,"type":20},"2024-11",{"name":226,"class":71},"Asociación para Evitar la Ceguera en México",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":234,"targetDuration":236,"studyType":21,"phases":4,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100434623","european-disease-registry-on-retinopathy-of-prematurity-rop-100434623","NCT04939571","European Disease Registry on Retinopathy of Prematurity (ROP)","EU-ROP","Inclusion Criteria:\n\n* ROP requiring treatment according to the respective national ROP screening and treatment guidelines\n\nExclusion Criteria:\n\n* Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians",{"count":235,"type":20},3000,"18 Years","The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed.\n\nThe aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited.\n\nThe primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.",[24],[27,240,241,242,243],"anti-VEGF","laser coagulation","epidemiology","non-interventional study","2024-01-22",{"date":246,"type":32},"2024-01-24",{"date":248,"type":32},"2021-08-06",{"date":250,"type":20},"2039-08",{"name":252,"class":71},"University Medicine Greifswald",59,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":49,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100394752","clinical-and-genetic-analysis-of-rop-100394752","NCT04420156","Clinical and Genetic Analysis of ROP","Clinical and Genetic Analysis of Retinopathy of Prematurity","(ROP)","Inclusion Criteria:\n\n* All infants hospitalized at participating Neonatal Intensive Care Units will be eligible for the study if they meet plublished criteria for requiring ROP screening examination, or if they are transferred to the study center for specialized ophthalmic care. These eligibility criteria are identical at each study center, and match what is done in standard clinical practice according to national guidelines published jointly by the American Academy of Pediatrics, American Academy of Ophthalmology, and American Associatioin for Pediatric Ophthalmology and Strabismus (AAP-AAO, Pediatrics, 2013).\n\nExclusion Criteria:\n\n* Patients will be excluded if they have structural ocular anomalies, or if they are considered unstable for examintion by their attending neonatologist.",{"count":263,"type":20},2000,"Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investigators feel that this study will result in specific knowledge discovery about ROP, as well as general knowledge about how image-based data and genetic data can be combined to better understand clinical disease.\n\nParticipants will be recruited from the neonatal intensive care unit (NICU) at OHSU, along with 4 collaborating institutions (William Beaumont Hospital, Stanford University, University of Illinois Chicago and University of Utah). Hospitalized infants who receive ROP screening examinations for routine care will be eligible for this study, and will be offered the opportunity to participate. Subjects who provide informed consent will have clinical data from routine care collected along with demographic characteristics, results from routine ROP screening examinations, presence of systemic disease or risk factors. Retinal photographs will be taken during these routine eye exams, using a commercially-available camera that has been FDA-cleared for taking pictures from retinas of premature infants. These retinal pictures do not contain any identifiable patient information, and are taken as routine standard of care.\n\nThe long-term goal of this research is to establish a quantitative framework for retinopathy of prematurity (ROP) care based on clinical, imaging, genetic, and informatics principles. The investigators have previously recruited and rigorously phenotyped and genotyped a large study cohort, including implementation of a novel reference standard diagnosis; and built a world-class research consortium for image, genetic, and bioinformatics analysis.",[24],[267,268,269],"ophthalmology","neonatology","prematurity","2022-04-18",{"date":272,"type":32},"2022-04-20",{"date":274,"type":32},"2011-07-01",{"date":276,"type":20},"2030-05-31",{"name":278,"class":71},"Oregon Health and Science University",5]