[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-infant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,48,83,117,144,175,198,228,256,283,309,335,366,390],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100349133","30-or-60-oxygen-at-birth-to-improve-neurodevelopmental-outcomes-in-very-low-birthweight-infants-100349133",false,"NCT03825835","30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants","Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial","HiLo","Inclusion Criteria:\n\n* Infants born at 23 0\u002F7 weeks to 28 6\u002F7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities\n\nExclusion Criteria:\n\n* Infants who are outborn - initial resuscitation not performed at the study centre\n* Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants\n* Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes\n* Infants who will not receive full resuscitation at birth- these infants will not receive resuscitation","ALL","0 Minutes","10 Minutes",{"count":21,"type":22},1200,"ESTIMATED","INTERVENTIONAL",[25],"NA","Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before 29 weeks' gestation. At this gestational age, the lungs are not fully developed and it is not uncommon for infants to have problems breathing at the time of birth. One complication that can arise is when an infant stops breathing and needs to be resuscitated. When preterm babies need to be resuscitated doctors must take special care because of the small infant size and the immaturity of the brain and lungs. Oxygen is used to resuscitate babies who need it, but unfortunately there is disagreement about the best oxygen concentration to use. Oxygen concentration is important because both too much and too little oxygen can cause brain injury. This research aims to fill this knowledge gap by participating in an international clinical trial to compare the effects of resuscitating babies less than 29 weeks' gestational age with either a low oxygen concentration or a high oxygen concentration. The oxygen concentrations have been selected using the best available knowledge.\n\nThis will be a cluster randomized trial where each participating hospital will be randomized to either 30 or 60 percent oxygen for the recruitment of 30 infants, and afterwards randomized to the other group for the recruitment of another 30 infants. After the trial, the investigator will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. This research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.",[28,29,30],"Premature Infant","Respiratory Distress Syndrome in Premature Infant","Neurodevelopmental Outcome",[32,33,28,34],"Delivery Room","Resuscitation","Oxygen","RECRUITING","2026-05-22",{"date":38,"type":39},"2026-05-26","ACTUAL",{"date":41,"type":39},"2022-06-27",{"date":43,"type":22},"2029-12-30",{"name":45,"class":46},"University of Alberta","OTHER",21,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100629377","intraventricular-hemorrhage-in-kangaroo-care-vs-incubator-care-100629377","NCT07473882","Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care","Kangaroo Care in Extremely Preterm Newborns Versus Incubator Care and Intraventricular Hemorrhage: A Multicenter RCT","KANVIH","Inclusion Criteria:\n\n* Preterm infants born at 28 weeks of gestational age or less, admitted to the NICU and born at the study center (inborn), less than 72 hours old, with a parent or legal guardian present who is willing to provide kangaroo care.\n\nExclusion Criteria:\n\n* Preterm infants in the immediate postoperative period following major surgery.\n* Preterm infants with congenital abdominal wall malformations.\n* Preterm infants requiring immobilization.\n* Preterm infants who are clinically unstable and unable to tolerate kangaroo care.\n* Preterm infants whose parents decline participation in the study.","1 Minute","72 Hours",{"count":59,"type":22},314,[25],"This clinical study aims to find out whether kangaroo care (skin-to-skin contact between parents and their extremely premature newborns) can help protect the babies' brains by reducing the risk of bleeding in the brain during the first days of life. To do this, the extremely premature newborns will be randomly assigned to one of three groups: kangaroo care in a side-lying position, kangaroo care in a face-down position, or standard care in an incubator. Researchers will monitor the babies for signs of brain bleeding and other health measures to determine which approach is safest. The main hypothesis is that kangaroo care in the side-lying position may lower the risk of severe brain bleeding compared with the other positions or remaining in the incubator.",[63,28,64],"Kangaroo Care","IVH- Intraventricular Hemorrhage",[66,67,68,69,70,71],"patient positioning","kangaroo-Mother care Method","Skin to Skin","Extremely Premature Infant","cerebral hemorrhage","incubator care","NOT_YET_RECRUITING","2026-03-11",{"date":75,"type":39},"2026-03-16",{"date":77,"type":22},"2027-01-01",{"date":79,"type":22},"2029-12-31",{"name":81,"class":46},"Hospital Universitario 12 de Octubre",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":82},"100597598","effects-of-oral-stimulation-performed-by-parents-to-improve-sucking-in-neonates-hospitalized-in-the-nicu-100597598","NCT07060573","Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU","Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Neonates with corrected gestational age of 34 to 36 weeks\n* Clinically stable to receive oral stimulation\n* Informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Orofacial congenital malformations\n* Severe neuromuscular disease\n* Conditions contraindicating oral feeding","34 Weeks","36 Weeks",{"count":93,"type":22},32,[25],"This randomized clinical trial aims to evaluate the effectiveness of an oral stimulation program to improve sucking in preterm neonates hospitalized in the NICU. The study compares two groups: one receiving the intervention from a physiotherapist and the other from trained parents. The stimulation program includes 4 extraoral and 4 intraoral exercises applied once daily for 14 consecutive days. The primary outcome is improvement in the POFRAS score. Secondary outcomes include the time to exclusive oral feeding, nasogastric tube withdrawal, weight at discharge, hospital stay duration, and parental adherence. This study addresses the potential role of parent participation in neonatal rehabilitation in public hospitals with limited human resources.",[28,97],"Sucking Behavior",[99,100,101,102,103,104,105,106,107],"Premature infant","sucking","oral stimulation","POFRAS","NICU","feeding","physiotherapy","Rehabilitation","parental involvement","2026-02-17",{"date":110,"type":39},"2026-02-19",{"date":112,"type":39},"2025-07-18",{"date":114,"type":22},"2027-02",{"name":116,"class":46},"Hospital Civil de Guadalajara",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":82},"100624532","virtual-reality-enhanced-parent-education-in-neonatal-intensive-care-100624532","NCT07410858","Virtual Reality-Enhanced Parent Education in Neonatal Intensive Care","Virtual Reality-Enhanced Parent Education and Its Effect on Neonatal Intensive Care Practices: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Parent or legal guardian of a neonate admitted to the Neonatal Intensive Care Unit (NICU) within 72 hours of admission\n* Age 18 years or older\n* Able to read and understand the study language (Arabic)\n* Willing to provide informed consent and participate in study procedures\n\nExclusion Criteria:\n\n* Parent with a confirmed diagnosis of epilepsy, vestibular disorder, or any medical condition that contraindicates virtual reality exposure\n* Parent of a neonate expected to be discharged or transferred within 48 hours\n* Parent unable to complete study procedures or assessments","18 Years",{"count":126,"type":22},60,[25],"This randomized pilot clinical trial aims to evaluate the effectiveness and feasibility of virtual reality (VR)-enhanced parent education in improving neonatal intensive care unit (NICU) caregiving practices among parents of hospitalized neonates. The study will also examine the safety and tolerability of VR use among parents.\n\nResearchers will compare VR-enhanced education with standard NICU parent education to determine whether immersive VR training improves parents' knowledge, confidence, and ability to perform caregiving tasks.\n\nParticipants will be randomly assigned to receive either VR-enhanced education or standard education. Participants receiving VR education will engage in short immersive sessions demonstrating NICU orientation and caregiving procedures. All participants will complete assessments and observations related to caregiving practices and VR tolerability throughout the study period.",[130,28,131,132,133],"Neonatal Intensive Care Units","Parent Education","Virtual Reality","Health Knowledge, Attitudes, Practice",[132,130,131,28],"2026-02-13",{"date":137,"type":39},"2026-02-18",{"date":139,"type":39},"2026-01-01",{"date":141,"type":22},"2026-04-30",{"name":143,"class":46},"Jouf University",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100569011","intervention-for-neurodevelopmental-support-in-preterm-infants-using-responsive-parenting-and-e-health-100569011","NCT06688695","Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health","Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n\\* Infant born before 32 GV, or with birth weight under 1500 gr.\n\nExclusion Criteria:\n\n* Parent(s) younger than 18 ya.\n* Chromosomal abnormalities, congenital syndromes that may affect the child's development.\n* Parents unable to understand Swedish.\n* Parents with severe mental illness or a physical medical condition requiring extensive inpatient care.\n* Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden.\n* Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.","0 Months","4 Months",{"count":155,"type":22},176,[25],"Research problem and specific questions More than 1000 very preterm infants (\\&amp;amp;lt; 32 weeks) are born every year in Sweden. They are at high risk of neurodevelopmental disabilities and mental illness throughout the lifespan.\n\nThe overall purpose is to develop and evaluate a novel e-health intervention aimed at improving neurodevelopment (cognitive, motor, feeding, language, socio-emotional) of very preterm infants by supporting responsive parenting behaviours.\n\nThe primary research question is whether the intervention improves child neurodevelopment up to 2 years.\n\nFurther research questions relate to the emotional availability of parents and children, parental stress and overall experience as well as effects on health inequalities and gender effects.\n\nData and method Using a multi-professional approach, the study team have developed a post-discharge \"Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health\" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period.\n\nThe study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age.\n\nSocietal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program.\n\nPlan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities",[28,159],"Premature Babies",[161,162,163,164],"Early intervention","Responsive parenting","E-health","Prematurity","2026-01-27",{"date":167,"type":39},"2026-01-28",{"date":169,"type":39},"2024-11-20",{"date":171,"type":22},"2029-10",{"name":173,"class":46},"Umeå University",7,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":82},"100616811","perinatal-risk-factors-in-motor-development-100616811","NCT07310459","Perinatal Risk Factors in Motor Development","Evaluation of Perinatal Risk Factors in Future Gross Motor Development of Preterm Infants: a Cross-sectional Study","Inclusion Criteria:\n\n* preterm infants showing biological risk factors\n* parents or tutors signe an informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of encephalopathy\n* genetic syndromes\n* congenital malformations\n* neuromuscular disorders\n* myopathies\n* metabolic and oncologic diseases","18 Months",{"count":184,"type":22},160,"OBSERVATIONAL","The aim of this study is to analyze the effect of preterm gestational age, birth weight and perinatal risks factors on gross motor development of preterm infants.\n\nWe will compare the data of infants evaluated by the Alberta Infant Motor Scale (AIMS) and the Perinatal Risk Inventory (PERI) in an Infant Development and Early Intervention Center (IDEIC).",[28,188,189],"Risk Factors","Motor Development of Premature Infants","2025-12-15",{"date":192,"type":39},"2025-12-30",{"date":194,"type":22},"2026-02-01",{"date":141,"type":22},{"name":197,"class":46},"Universidad de Murcia",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":227},"100532409","feeding-tolerance-and-growth-of-preterm-infants-consuming-a-supplement-containing-two-human-milk-oligosaccharides-hmos-100532409","NCT06212427","Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)","Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \\[LAR\\], if applicable)\n2. Infant's parent(s)\u002FLAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol\n3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound\n4. Infant birth weight ≤ 2500g\n5. Infant postnatal age ≤ 14 days\n6. Infant has tolerated trophic feeds (e.g., 10-15 mL\u002Fkg\u002Fday) for at least 24 hours but has not yet reached full enteral feeding\n\nExclusion Criteria:\n\n1. Infant is clinically unstable, for example:\n\n   1. Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP \\\u003C 5th percentile for age for at least three hours), or is receiving vasopressor drugs\n   2. Infant has received an exchange transfusion within the past 48 hours\n   3. Infant has had an episode of severe asphyxia at birth (PH less than 7.0)\n   4. Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)\n2. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)\n3. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study\n4. Participation in another interventional clinical study that may interfere with the results of this study","0 Days","14 Days",{"count":208,"type":22},188,[25],"The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \\[2'FL\\] and lacto-N-neotetraose \\[LNnT\\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.\n\nA comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.",[28,212],"Low Birthweight Infant",[214,215,216],"Human Milk Oligosaccharides","Feeding tolerance","Growth","2025-12-01",{"date":219,"type":39},"2025-12-08",{"date":221,"type":39},"2023-11-20",{"date":223,"type":22},"2026-02-28",{"name":225,"class":226},"Société des Produits Nestlé (SPN)","INDUSTRY",6,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":254,"locationsCount":82},"100613115","calmer-brains-in-very-preterm-infants-100613115","NCT07262385","Calmer Brains in Very Preterm Infants","Calmer Brains: A Pilot Randomized Trial to Explore Structural and Functional Brain Development in Preterm Infants","Inclusion Criteria:\n\n* Very preterm infants admitted to the NICU at the BC Women's Hospital\n\nExclusion Criteria: Infants who have\n\n* Congenital anomalies;\n* Born small for GA (per medical admission history);\n* History of birthing parent substance use in pregnancy;\n* Ongoing infection at the time of enrollment;\n* Pre-existing cardiovascular instability defined by shock\u002Fhypotension\u002Fneed for cardiovascular drugs;\n* Receiving paralytic drugs;\n* Major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage\u002Fstroke; VP shunt);\n* Beyond the 30th completed week GA (30 weeks + 6 days) at enrollment.","26 Weeks","30 Weeks",{"count":238,"type":22},20,[25],"Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development. Calmer was invented to mimic key parts of parental holding (touch, heartbeat sounds and breathing motion) to help reduce stress if parents cannot be there to hold their infant. Using specialized brain scans done at full term, we will gather initial information in 22 infants born 3-4 months early to compare brain development in infants who receive Calmer at least 3 hours each day (+ regular NICU care) over 2-3 weeks with infants who have regular NICU care.",[28],[164,243,244,103,245,246,247],"Brain development","Stress","Pilot RCT","Feasibility","Calmer - therapeutic medical device","2025-11-21",{"date":250,"type":39},"2025-12-03",{"date":217,"type":22},{"date":253,"type":22},"2027-09",{"name":255,"class":46},"University of British Columbia",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":263,"sex":17,"minAge":206,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":82},"100346933","genesis-electrical-impedance-tomography-eit-a-preliminary-study-100346933","NCT03797183","Genesis Electrical Impedance Tomography (EIT): A Preliminary Study","The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study","Inclusion Criteria:\n\n* 2 weeks old - 40 years old\n* Premature infants with current age \\>2 weeks with a confirmed diagnosis of BPD based on NIH criteria\n* Or Chronic respiratory disease due to underlying neuromuscular disease\n* Or confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of DMD or other diagnoses associated with mild cardiomyopathy.\n* have had a VQ scan\n* will be undergoing cardiac catherization for for pulmonary vein stenosis, pulmonary hypertension and\u002For pulmonary artery stenosis\n* Or healthy controls\n\nExclusion Criteria:\n\n* \\\u003C2 weeks of age\n* Congenital diaphragmatic hernia\n* Severe congenital heart disease\n* Significant genetic abnoralities\n* Anything that interferes with lead placement on the chest wall\n* Unwilling\u002Frefusal to sign consent\n* Pregnant or lactating\n* Pacemaker of other surgical implant and spinal implant (causes noise in the data)\n* Moderate to severe cardiomyopathy\n* Patients with temporary cognitive disability due to illness",true,"40 Years",{"count":266,"type":22},90,"The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.",[28,269,270,271,272,273],"Chronic Respiratory Disease","Neuromuscular Diseases","Healthy","Bronchopulmonary Dysplasia","Pulmonary Vein Stenoses","2025-11-11",{"date":276,"type":39},"2025-11-13",{"date":278,"type":39},"2019-05-03",{"date":280,"type":22},"2026-11",{"name":282,"class":46},"University of Colorado, Denver",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":263,"sex":290,"minAge":4,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":299,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":82},"100597000","development-and-effectiveness-evaluation-of-a-clustered-care-guideline-within-individualized-developmental-care-rct-100597000","NCT07052786","Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT","Guideline","Inclusion Criteria:\n\n* Working in the NICU of Necmettin Erbakan University Medical Faculty Hospital,\n\n  * Having at least 3 months of experience in the NICU,\n  * Volunteering to participate in the research.\n\nExclusion Criteria:\n\n* The nurse wanting to leave the study during the study\n\n  * The nurse not participating in the training or not completing the training\n  * The nurse not being able to complete the study, including the final","FEMALE",{"count":292,"type":22},44,[25],"The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability. It supports the practice of clustered care, which refers to grouping routine medical and nursing procedures into a single care time period to reduce handling and allow the infant uninterrupted rest and maintenance of the sleep-wake cycle.\n\nThis study aims to develop a clustered care practice guideline and evaluate its effectiveness. The study was designed as a single-blind randomized controlled trial, where the participating nurses will not be informed about their group allocation (intervention or control) to reduce bias.The study will be conducted between July and September 2025 in the level 2 and 3 NICUs of Necmettin Erbakan University Faculty of Medicine Hospital in Konya, Turkey.\n\nThe study population includes all 44 nurses working in these NICUs who meet the inclusion criteria and agree to participate. Since the entire population is accessible, total population sampling will be used. After data collection is completed, a post hoc power analysis will be conducted using G\\*Power (v3.1.9.2).\n\nData will be collected using the \"Descriptive Information Form for the Infant and the Nurse\" and the \"Clustered Care Practice Guideline\". Pre-test data will be collected before training, and post-test data will be collected 4-6 weeks after the training.\n\nThe intervention group will receive the Clustered Care Practice Training Based on Individualized Developmental Care in two in-person sessions (approx. 45 minutes per session), delivered in small groups (11-12 participants). A training booklet prepared by the researchers will be distributed at the end of the sessions.\n\nThe normality of the data will be assessed using the Kolmogorov-Smirnov test, normal distribution curves, and skewness-kurtosis values. Parametric tests will be used for normally distributed data; non-parametric tests will be used otherwise. A significance level of P\\\u003C0.05 will be applied.\n\nEthical approval was obtained from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research (decision no: 2022\u002F014, date: 21.06.2022). Institutional permission was obtained from NEU Faculty of Medicine Hospital. Written informed consent will be obtained from all participating nurses and from parents of the observed infants.",[28,296,297,298],"Clustered Care","Neonatal Intensive Care Unit","Developmental Care",[300],"clustered care, guideline,nurse, NICU","2025-09-08",{"date":303,"type":39},"2025-09-15",{"date":305,"type":39},"2025-07-01",{"date":192,"type":22},{"name":308,"class":46},"KTO Karatay University",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":316,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":82},"100533456","growing-little-peapods-study-100533456","NCT06226051","Growing Little PEAPODS Study","Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes","Neonate Inclusion Criteria:\n\n* Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d)\n\nNeonate Exclusion Criteria:\n\n* Known genetic condition that impacts neurodevelopmental outcomes or brain structure development\n* Multiple major congenital anomalies\n* Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA\n\n  * Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD\n\nBirthing Parent Inclusion Criteria:\n\n* Birthing parent must speak English or Spanish due to consent documents\n* Able to understand and willing to sign a written informed consent document\n* Primary caregiver of a neonate who is eligible to participate in the study\n* Agrees to enroll neonate into the study\n* Willing to comply with all study procedures and be available for the duration of the study\n* Age 15 or older\n\nBirthing Parent Exclusion Criteria:\n\n* Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody\n* Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy","22 Weeks","32 Weeks",{"count":319,"type":22},120,"The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development.\n\nParticipants will:\n\n* have body growth measurements collected using the PEAPOD device\n* have nutritional information collected, and\n* be followed for neurodevelopmental outcomes\n\nParticipants can expect to be in the study for 36 months.",[322,28,323,324,325],"Premature Birth","Premature","Intrauterine Growth Restriction","Small for Gestational Age at Delivery","2025-08-07",{"date":328,"type":39},"2025-08-12",{"date":330,"type":39},"2024-09-04",{"date":332,"type":22},"2028-01",{"name":334,"class":46},"University of Wisconsin, Madison",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":263,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":351,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":82},"100355322","preventing-vulnerable-child-syndrome-in-the-nicu-with-cognitive-behavioral-therapy-prevnt-trial-100355322","NCT03906435","Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)","Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy","PreVNT","Inclusion Criteria:\n\n* Born at Parkland Hospital\n* English or Spanish speaking mother +\u002F- father\n* ≤ 30.6 weeks gestation at birth\n* Survival to 33 weeks gestation\n\nExclusion Criteria:\n\n* Significant congenital anomalies\n* Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.",{"count":344,"type":22},100,[25],"This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.",[28,348,349,350],"Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)","Development, Child","Parent-Child Relations",[352,297,353,354,355,356],"Vulnerable Child Syndrome","Cognitive Behavioral Therapy","Parental Perception of Child Vulnerability","Child Developmental Outcomes","Parent Mental Health","2025-06-10",{"date":359,"type":39},"2025-06-13",{"date":361,"type":39},"2019-04-15",{"date":363,"type":22},"2026-12-01",{"name":365,"class":46},"University of Texas Southwestern Medical Center",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":82},"100568626","high-flow-nasal-cannula-for-stabilization-of-extremely-premature-infants-100568626","NCT06683677","High Flow Nasal Cannula for Stabilization of Extremely Premature Infants","High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Extremely Premature Infants: a Prospective Observational Study","SIMPLSAFE2","Inclusion Criteria:\n\n* Preterm infants born between 25+0 and 27+6 gestational weeks\n* Weight above 500 grams\n\nExclusion Criteria:\n\n* Previable rupture of membranes,\n* Congenital malformations previable\n* Acute intrauterine hypoxia.","2 Minutes",{"count":126,"type":22},[25],"A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 6-8 l\u002Fmin is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low Saturation of oxygen (SpO2).",[28,379,380],"Ventilation Therapy","High Flow Nasal Canula","2024-11-12",{"date":383,"type":39},"2024-11-14",{"date":385,"type":22},"2024-12-01",{"date":387,"type":22},"2029-07-01",{"name":389,"class":46},"Charles University, Czech Republic",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":4},"100557859","comparing-of-high-flow-nasal-cannula-versus-cpap-for-initial-respiratory-stabilisation-of-very-premature-infants-100557859","NCT06543589","Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants","A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants","SIMPLSAFE3","Inclusion Criteria:\n\n* Gestational age at birth between 28+0 and 31+6 weeks by the best obstetric estimate.\n* Written informed consent from parent\u002Flegal guardian(s) is obtained before delivery.\n\nExclusion Criteria:\n\n* Peripartal hypoxia with pH \\\u003C 7,1\n* Significant congenital malformations.\n* IUGR with estimated weight of fetus below 800g.\n* Condition that has an adverse effect on breathing\u002Fventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.\n* Documented decision to give palliative neonatal care.","5 Minutes",{"count":400,"type":22},443,[25],"Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.",[404],"Premature; Infant","2024-11-08",{"date":381,"type":39},{"date":408,"type":22},"2024-12",{"date":410,"type":22},"2026-09",{"name":389,"class":46}]