[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preterm-infants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preterm-infants":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,67,95,126,156],{"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":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100642598","neonatal-wireless-transmission-system-hospital-adoption-and-planning-for-implementation-study-100642598","NCT07650045","Neonatal Wireless Transmission System: Hospital Adoption and Planning for Implementation Study","NEWTS HAPI-1","Inclusion Criteria:\n\n* staff with experience of working or supporting NICU care Informed consent\n\nExclusion Criteria:\n\n* no informed consent",true,"18 Years","65 Years",{"count":52,"type":20},50,"To explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.",[25,55],"Vital Sign Monitoring","NOT_YET_RECRUITING","2026-06-11",{"date":59,"type":32},"2026-06-16",{"date":61,"type":20},"2026-07-01",{"date":63,"type":20},"2026-12-31",{"name":65,"class":66},"Cambridge University Hospitals NHS Foundation Trust","OTHER",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":40},"100633146","physiological-safety-and-behavioral-comfort-of-swaddle-bathing-in-preterm-infants-100633146","NCT07522892","Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants","Effects of Swaddle Bathing on Physiological Regulation and Stress-Reducing Behaviors in Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial","Inclusion Criteria\n\n* Gestational age between 32 and 36 weeks and 6 days\n* Birth weight greater than 1,500 grams\n* Clinically stable as determined by the attending neonatologist\n* Receiving the first bath after birth\n\nExclusion Criteria\n\n* Major congenital anomalies, such as cyanotic heart disease, gastroschisis, or open spinal defects\n* Severe intraventricular hemorrhage (Grade III or IV)\n* Skin impairments or open wounds that contraindicate water immersion, including surgical sites\n* Continuous use of sedatives or muscle relaxants that may interfere with behavioral assessments","1 Day","7 Days",{"count":77,"type":20},40,"INTERVENTIONAL",[80],"NA","Background and Purpose: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU). However, traditional tub bathing can be a significant source of stress for these vulnerable infants, potentially leading to fluctuations in body temperature, heart rate, and oxygen levels. Swaddle bathing-a technique where the infant is wrapped in a light cloth during the bath-is thought to provide a sense of security and better physiological stability.\n\nThe goal of this pilot randomized controlled trial is to compare the effects of swaddle bathing versus conventional tub bathing in preterm infants. The researchers want to determine if swaddle bathing is as safe as traditional methods while being more comfortable for the baby.\n\nMain Questions to Answer:\n\n* Is swaddle bathing non-inferior to (as safe as) conventional tub bathing regarding the infant's physiological stability (e.g., body temperature and heart rate)?\n* Does swaddle bathing significantly reduce stress-related behaviors and crying in preterm infants compared to conventional bathing?\n\nStudy Design and Procedure:\n\nParticipants will be randomly assigned to one of two groups:\n\n1. Experimental Group: Infants will receive swaddle bathing, where they remain snugly wrapped in a towel or wrap while being gently immersed in water.\n2. Control Group: Infants will receive conventional tub bathing according to standard hospital protocols.\n\nDuring and after the bath, the research team will monitor the infants' vital signs and video-record their behavioral responses (such as facial expressions and limb movements) to evaluate their level of comfort and stress. The results of this study will provide preliminary evidence to help clinical nurses decide the best bathing practices for promoting the neurodevelopmental care of preterm infants.",[25],[84,85],"swaddle bath","preterm infants","2026-04-09",{"date":88,"type":32},"2026-04-14",{"date":90,"type":32},"2024-04-24",{"date":92,"type":20},"2026-05-31",{"name":94,"class":66},"Chang Gung University of Science and Technology",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":78,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100625120","phase-2-pressure-targeting-during-high-flow-therapy-in-premature-infants-100625120","NCT07418502","Pressure Targeting During High Flow Therapy in Premature Infants","A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants","NeoMATCH","Inclusion Criteria:\n\n* Delivery at \\>24+0 weeks and ≤32+6 weeks of gestation\n* Postnatal age \\>7 days but \\\u003C 6 weeks old\n* Weight ≥1,000grams at the time of study\n* Receiving clinically prescribed CPAP at pressures of 5-8cm H2O\n* Requiring an FiO2 of ≤0.60\n\nExclusion Criteria:\n\n* Chromosomal disorder (aneuploidy)\n* Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)\n* Prior pneumothorax\n* Infants in whom chance of survival is uncertain","40 Weeks",{"count":105,"type":20},78,[107],"PHASE2","The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is:\n\nDoes Pressure Targeted High Flow provide enough support in premature infants?\n\nParticipants will:\n\nTake spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored.",[25,110,111],"Respiratory Distress Syndrome (Neonatal)","BPD - Bronchopulmonary Dysplasia",[113,114,115],"preterm","CPAP","High Flow","2026-02-10",{"date":118,"type":32},"2026-02-18",{"date":120,"type":20},"2026-05-01",{"date":122,"type":20},"2027-09",{"name":124,"class":66},"University of Texas at Austin",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":78,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":155},"100620967","protocol-driven-nutrition-in-preterm-infants-100620967","NCT07364500","Protocol-driven Nutrition in Preterm Infants","Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition","Inclusion Criteria:\n\n* Infants born before 31+6 weeks gestation.\n* Signed consent for participation in the project and consent for the processing of personal data.\n* Admission to neonatal care in the participating hospital within 24 hours after birth.\n\nExclusion Criteria:\n\n* Congenital malformations.\n* Fetal hydrops.\n* Intraventricular hemorrhage requiring drainage.\n* Necrotizing enterocolitis requiring surgical treatment.\n* Surgically treated hydrocephalus.\n* Unsigned consent for participation in the project and\u002For consent for the processing of personal data.","22 Weeks","32 Weeks",{"count":136,"type":20},400,[80],"The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.\n\nThe primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns in the field of nutrition. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.",[25],[85,141,142,143,144],"nutrition of preterm infants","human milk analysis","nutrition monitoring","Czech Republic","2026-01-21",{"date":147,"type":32},"2026-01-23",{"date":149,"type":32},"2025-08-21",{"date":151,"type":20},"2027-02",{"name":153,"class":154},"Institute of Health Information and Statistics of the Czech Republic","OTHER_GOV",5,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":48,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":164,"targetDuration":166,"studyType":21,"phases":4,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":125},"100523195","the-intestinal-innate-immune-system-in-newborns-development-and-inflammation-in-health-and-disease-100523195","NCT06092463","The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease","The Intestinal Innate Immune System in Newborns. Development and Inflammation in","INTINE","Inclusion Criteria:\n\nNEC study\n\n* Premature infants born \\\u003C GA week 32 Atresia study\n* All newborn and children up to 1 year of age who needs to undergo intestinal surgery due to atresia at any site of the intestine.\n\nExclusion Criteria:\n\nNEC study - Premature born with congenital diseases or other serious conditions which may defer participation. Situations where collection of tissue at surgery is impossible or problematic e.g. due to remaining length of vital intestine is evaluated to be too short according to the discretion of the operating surgeon.\n\nAtresia study\n\n-Infants and children where intestinal tissue sampling would compromise surgery and the health of the patient subsequent.",{"count":165,"type":20},275,"60 Days","The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life. The main questions aim to answer are:\n\n* to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life.\n* is to investigate the development of the immune system in relation to enteral nutrition during the neonatal period.\n\nParticipants will be asked to give faecal samples from day 1 of life and weekly for the following weeks until discharge (preterm infants). Further, surgery faecal samples and intestinal tissue will be collected proximal and distal to the pathology. In cases with a stoma, and when the child will undergo later reversal surgery, tissue samples from the proximal and distal ends of the intestine will be collected together with fecal samples (preterm and children up to 1 year of age who need to undergo intestinal surgery due to atresia).",[25,169,170,171,172],"Term Infants","Necrotising Enterocolitis","Atresia; Bowel","Innate Inflammatory Response",[174,175,176,177],"IgA","mRNA sequencing","Nutritional support","Bowel habbits","2025-05-17",{"date":180,"type":32},"2025-05-21",{"date":182,"type":32},"2024-02-02",{"date":184,"type":20},"2029-10-30",{"name":186,"class":66},"Rigshospitalet, Denmark"]