[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extremely-premature-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extremely-premature-infant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,88,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100631599","heterologous-cord-blood-derived-red-blood-cell-for-transfusion-in-extremely-preterm-infants-100631599",false,"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.","ALL","23 Weeks","28 Weeks",{"count":20,"type":21},176,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34,35],"Extremely Premature Infant","Anemia Neonatal","Blood Transfusion","Umbilical Cord Blood","Fetal Hemoglobin","Bronchopulmonary Dysplasia (BPD)","Retinopathy of Prematurity (ROP)","Death; Neonatal","Intensive Care Units, Neonatal",[37,38,39,40,41,42,43,44,45,46],"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","NOT_YET_RECRUITING","2026-03-27",{"date":50,"type":51},"2026-03-31","ACTUAL",{"date":53,"type":21},"2027-01",{"date":55,"type":21},"2029-12",{"name":57,"class":58},"Hospital Clinic of Barcelona","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100629950","creation-of-a-scale-for-assessing-pain-and-discomfort-in-extremely-premature-infants-edex-hospitalised-in-neonatal-intensive-care-inspired-by-the-early-infant-pain-and-discomfort-scale-edin-100629950","NCT07481331","Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Discomfort Scale (EDIN)","Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Distress Scale (EDIN)","DOU-PREMA","Inclusion Criteria:\n\nExtremely premature infants:\n\n* born before 27 weeks of gestation, and aged no more than 26 weeks of amenorrhea + 6 days in corrected age,\n* from 48 hours of life,\n* hospitalised in neonatal intensive care,\n* for whom at least one of the two legal guardians has given their consent.\n\nExclusion Criteria:\n\nExtreme premature infants:\n\n* whose clinical condition is critical with a risk of imminent death,\n* with major brain damage (HIV 4) or major brain malformations,\n* deeply sedated or paralyzed with no spontaneous reactions,\n* whose parents are both minors.\n* who are not already participating in another study.","27 Weeks",{"count":70,"type":21},68,"OBSERVATIONAL","The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which will be called the EDEX (Extremely Premature Infant Pain Assessment Scale).\n\nThis scale will take into account the level of development of extremely premature infants, recognizing that the perception and manifestations of pain vary according to gestational age.\n\nIt was chosen to develop a specific pain assessment scale for preterm infants born before 27 weeks of gestation, in line with their level of development and their relatively homogeneous manifestations in this population.\n\nThis population, which is the most immature, is particularly fragile and sensitive to its environment and the care provided. Pain manifestations are the most subtle, vegetative reactions are very present, and the motor system is still underdeveloped, linked to low muscle tone.\n\nIt is with this category of patients that the nursing staff encounter the most difficulty in assessing pain and discomfort based on the EDIN scale.\n\nAfter creating the new EDEX scale during the first phase of the DOU-PREMA study, both scales (EDIN and EDEX) will be administered to the same pool of extremely premature infants during the second phase of the DOU-PRÉMA study in order to assess the correlation between the two scales.\n\nThe main hypothesis is that EDIN and EDEX scores will not be correlated, as the EDIN does not appear to be suitable for extremely premature infants in routine practice.\n\nif the hypothesis is confirmed, a multicenter psychometric validation of the EDEX scale will then be considered in a future study.\n\nThe study is a monocentric, non-interventional observational study conducted in the neonatal intensive care unit (NICU) of the University Hospital of Reunion Island (Site Nord). It is designed as a preliminary step toward the psychometric validation of a newly developed behavioral pain and discomfort assessment scale for extremely preterm infants (\\\u003C27 weeks' gestational age), named EDEX.\n\nThe study includes two sequential phases:\n\n1. a developmental phase dedicated to the creation of the EDEX scale : This stage is based on the production of videos of premature extreme in order to ajust the provisional scale define during a multidisciplinary meeting.\n2. a cross-sectional observational phase comparing EDEX with the EDIN scale in the same population.\n\nThe second phase of the project will evaluate the correlation between EDIN and EDEX scores.\n\nThis protocol follows the SPIRIT recommendations for study protocols involving human participants.",[27,74,75],"Pain","Discomfort Symptoms",[77,78],"pain and discomfort scale","extremely premature infants","2026-03-16",{"date":81,"type":51},"2026-03-18",{"date":83,"type":21},"2026-04",{"date":85,"type":21},"2028-02",{"name":87,"class":58},"Centre Hospitalier Universitaire de la Réunion",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100615729","vitamin-a-in-cord-blood-and-preterm-outcomes-100615729","NCT07296393","Vitamin A in Cord Blood and Preterm Outcomes","The Association Between Umbilical Cord Blood Vitamin A Levels and Adverse Outcomes in Extremely Preterm Infants: A Single-Center Prospective Cohort Study","Inclusion Criteria:\n\nGestational age \\\u003C32 weeks Birth at First Hospital of Jilin University Umbilical cord blood sample obtained within 24 h Parental written informed consent\n\nExclusion Criteria:\n\nMajor congenital malformation or chromosomal abnormality Refusal of consent","28 Days",{"count":97,"type":21},155,"This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (\\\u003C32 weeks' gestation) and to evaluate whether low cord blood vitamin A is associated with increased risk of neonatal morbidities such as bronchopulmonary dysplasia (BPD), necrotising enterocolitis (NEC), severe intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), periventricular leukomalacia (PVL), high-grade patent ductus arteriosus (hsPDA), respiratory distress syndrome (RDS), sepsis and death before discharge.",[27],"2025-12-09",{"date":102,"type":51},"2025-12-22",{"date":104,"type":21},"2025-12-10",{"date":106,"type":21},"2027-12-30",{"name":108,"class":58},"The First Hospital of Jilin University",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100546815","humidity-in-incubators-for-tiny-infants-100546815","NCT06399861","Humidity in Incubators for Tiny Infants","Humidity in Incubators for Tiny Infants (HumidITI) Trial","HumidITI","Inclusion Criteria:\n\n* Inborn infant of \\\u003C25 weeks' gestation admitted to the NICU\n\nExclusion Criteria:\n\n* Infants with known congenital skin conditions\n* Outborn infants\n* Infants with unknown gestational age prior to birth","0 Days","1 Day",{"count":120,"type":21},350,[24],"The objective of the study is to assess 2 different initial incubator humidification protocols for infants \\\u003C25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared.",[27],[125],"Humidification Protocol","RECRUITING","2025-10-27",{"date":129,"type":51},"2025-10-29",{"date":131,"type":51},"2024-06-25",{"date":133,"type":21},"2027-07-01",{"name":135,"class":58},"The University of Texas Health Science Center, Houston",6]