[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-intensive-care-unit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-intensive-care-unit":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100571911","critical-care-optimized-pediatric-and-neonatal-quantitative-neuromonitoring-100571911",false,"NCT06726408","Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring","Critical Care Optimized Pediatric Quantitative EEG","COPeQ","Inclusion Criteria :\n\n* Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring. The same patient may be included multiple times.\n* Written non-opposition from legal representatives.\n* Patients affiliated with or beneficiaries of a social security or similar scheme (CMU).\n\nExclusion Criteria :\n\n* Parents who do not understand French.\n* Inability to set up monitoring equipment (neurosurgery preventing access to electrode placement sites).\n* Corrected age \\\u003C 37 weeks of gestation (GA) for preterm infants.","ALL","24 Months",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques.\n\nThis project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.",[25],"Neonatal Intensive Care Unit",[27,28,29],"Quantitative neuromonitoring","Pediatric and neonatal critical care","Neonatal encephalopathy","RECRUITING","2026-03-06",{"date":33,"type":34},"2026-03-10","ACTUAL",{"date":36,"type":34},"2025-09-16",{"date":38,"type":21},"2027-09-16",{"name":40,"class":41},"Nantes University Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413","NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","0 Hours","48 Hours",{"count":54,"type":21},1444,"INTERVENTIONAL",[57],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[60,61,62,63,25,64,65],"Neonatal Hypoglycemia","Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Breastfeeding","Mental Health Issue",[67,68],"Pasteurised donor human milk","Donor breastmilk","2026-01-29",{"date":71,"type":34},"2026-02-02",{"date":73,"type":34},"2025-12-04",{"date":75,"type":21},"2028-12",{"name":77,"class":41},"The University of Queensland",4,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":55,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":42},"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",true,"FEMALE",{"count":89,"type":21},44,[91],"NA","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.",[94,95,25,96],"Premature Infant","Clustered Care","Developmental Care",[98],"clustered care, guideline,nurse, NICU","2025-09-08",{"date":101,"type":34},"2025-09-15",{"date":103,"type":34},"2025-07-01",{"date":105,"type":21},"2025-12-30",{"name":107,"class":41},"KTO Karatay University"]