[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preterm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preterm":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,47,76,103,133,175,200,228,259,295,323,355,384,407,434,461,486,510,530,556,569,595,618,643,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054167","comparative-outcomes-related-to-delivery-room-cord-milking-in-low-resourced-kountries--preterm-100054167",false,"NCT06240715","Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm","A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth","CORDMILK-PT","Inclusion Criteria:\n\n* Preterm infants born between 30 0\u002F7 weeks to 34 6\u002F7 weeks of gestation\n* Non-vigorous at birth\n\nExclusion Criteria:\n\n* Infants with congenital malformation\n* Major chromosomal abnormalities\n* Complete placental abruption\u002Fcutting through the placenta at the time of delivery\n* Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)\n* Mono-chorionic twins,\n* Twins with no information on amnion\u002Fchorion\n* Multiple gestation \\>2","ALL","0 Minutes","10 Minutes",{"count":22,"type":23},800,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.",[29,30],"Preterm","Infant Death",[29,32,33],"Umbilical cord milking","Placental transfusion","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2024-07-01",{"date":42,"type":23},"2027-03-30",{"name":44,"class":45},"Nemours Children's Clinic","OTHER",9,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100456946","sensory-optimization-of-the-hospital-environment-100456946","NCT05230199","Sensory Optimization of the Hospital Environment","Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit","SOOTHE","Inclusion Criteria:\n\n* ≤ 32 weeks estimated gestational age (EGA)\n* recruited within the first week of life\n\nExclusion Criteria:\n\n* \\> 32 weeks EGA at birth\n* \\>7 days old\n* become wards of the state\n* have a suspected or confirmed congenital anomaly\n* face a high immediate threat of death, per the opinion of the attending physician.","1 Day","7 Days",{"count":58,"type":23},215,[26],"The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.",[29,62,63,64,65],"Parent-Child Relations","Parents","Development, Infant","Sensory Integration Dysfunction","2026-06-15",{"date":68,"type":38},"2026-06-17",{"date":70,"type":38},"2023-05-29",{"date":72,"type":23},"2028-12-31",{"name":74,"class":45},"University of Southern California",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":75},"100638001","thyroxine-supplementation-in-small-for-gestational-age-sga-infants-with-birth-weight-1500g-and-tsh-6-20-miuml-100638001","NCT07625722","Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Inclusion Criteria:\n\n* Preterm infants born Small for Gestational Age (SGA) with a birth weight \\\u003C 1500g；\n* Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth；\n* Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU\u002FmL；\n* Written informed consent obtained from the parents.\n\nExclusion Criteria:\n\n* Diagnosis of Congenital Hypothyroidism (CH) with serum TSH \\> 20 mIU\u002FmL within the first 2 weeks of life and receiving L-T4 treatment;\n* Persistent serum TSH \\\u003C 6 mIU\u002FmL throughout the first 2 weeks;\n* Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;\n* Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;\n* Presence of major congenital malformations of vital organs or known chromosomal\u002Fgenetic disorders;\n* History of maternal thyroid disease or maternal use of thyroid-related medications.","2 Weeks",{"count":85,"type":23},106,[26],"The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug\u002Fkg\u002Fd, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights \\\u003C 1500g and TSH levels between 6 and 20 mIU\u002Fml. Preterm infants in the intervention group will receive 8 ug\u002Fkg\u002Fd of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.",[89,29,90,91],"Thyroid Function","SGA and Growth","Neurodevelopment Outcome","NOT_YET_RECRUITING","2026-05-29",{"date":95,"type":38},"2026-06-04",{"date":97,"type":23},"2026-06-20",{"date":99,"type":23},"2029-06-20",{"name":101,"class":102},"Shandong Provincial Hospital","OTHER_GOV",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":75},"100638936","safe-early-intervention-for-at-risk-infants-100638936","NCT07596147","SAFE Early Intervention for At-Risk Infants","Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants","SAFE-EFFECT","Inclusion Criteria:\n\n* Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki","3 Months","12 Months",{"count":114,"type":23},34,[26],"This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group.\n\nInfants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities.\n\nInfants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills.\n\nFamilies will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.",[118,119,29],"High Risk Infant","Neurodevelopmental Disorder (Diagnosis)",[121,122,123],"early intervention","high risk infant","upper limb function","2026-05-13",{"date":126,"type":38},"2026-05-19",{"date":128,"type":38},"2026-02-16",{"date":130,"type":23},"2026-07-16",{"name":132,"class":45},"Gazi University",{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":18,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":146,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":159,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100581994","assessing-intellectual-and-motor-outcomes-in-high-risk-infants-100581994","NCT06857539","Assessing Intellectual and Motor Outcomes in High-risk Infants","The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy","AIM-High","Inclusion Criteria (High Risk Group) :\n\n* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n* All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:\n\n  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight\n  * All encephalopathic infants\n  * Neurological risk factors (e.g., cerebral birth defect, injury\u002Fmalformation on neuroimaging, persistently abnormal neurological exam)\n\n(Control Group)\n\n-A control arm will also be recruited.\n\nExclusion Criteria:\n\n* Death prior to discharge from the neonatal unit (High-Risk Infants only)\n* No parental consent (High-Risk and Control Infants)",true,"0 Days","4 Months",{"count":145,"type":23},600,"30 Months","OBSERVATIONAL","Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.\n\nIn this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre\u002F University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.",[150,151,152,153,154,155,156,157,29,158],"Cerebral Palsy","Cerebral Palsy (CP)","Cerebral Palsy Children","High-risk Infants","Intellectual and Developmental Disabilities","Motor Impairment","Cognitive Development","HIE - Hypoxic - Ischemic Encephalopathy","Prematurity; Extreme",[150,160,161,162,163,164,165],"High-Risk Infant Follow-up","Motor Difficulty","Intellectual Delay","Cognitive Impairment","Hypoxic--Ischaemic Encephalopathy","Prematurity","2026-05-08",{"date":124,"type":38},{"date":169,"type":38},"2025-03-21",{"date":171,"type":23},"2030-07-31",{"name":173,"class":45},"University College Cork",4,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":141,"sex":18,"minAge":112,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":24,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100636155","investigation-of-allergen-sensitization-in-newborn-babies-diagnosed-with-necrotizing-enterocolitis-100636155","NCT07562009","Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis.","Allergy Risk and Sensitization Following Necrotizing Enterocolitis","AlisNEC","Inclusion Criteria:\n\n1. Infants born in our hospital and diagnosed with NEC during the study period.\n2. Age-matched control infants born in our hospital during the same period but without NEC diagnosis.\n3. Written and verbal informed consent obtained from at least one parent.\n\n   \\-\n\nExclusion Criteria:\n\n1. Infants whose parents did not provide written or verbal consent.\n2. Infants with major congenital anomalies.\n3. Infants with chromosomal disorders.\n4. Infants with gastrointestinal malformations (e.g., duodenal atresia, gastroschisis, omphalocele).\n5. Infants diagnosed with immunodeficiency. -","24 Months",{"count":185,"type":23},130,[26],"To evaluate the frequency of allergy between 12 and 24 months of age in infants who were treated in the neonatal clinic and had NEC. To investigate the relationship between NEC development and the development of allergy in the later period.",[189,190,29],"Necrotizing Enterocolitis","Allergy","2026-04-24",{"date":193,"type":38},"2026-05-01",{"date":195,"type":23},"2026-04-01",{"date":197,"type":23},"2028-01-01",{"name":199,"class":45},"Saglik Bilimleri Universitesi",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":208,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100621582","cerclage-plus-progesterone-vs-progesterone-alone-in-twin-short-cervix-100621582","NCT07372495","Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix","Cervical Cerclage Plus Vaginal Progesterone Versus Vaginal Progesterone Alone in Twin Pregnancies With a Short Cervix for Prevention of Preterm Birth: a Randomized Controlled Trial","VNTWINC","Inclusion Criteria:\n\n* Maternal age ≥ 18\n* Twin pregnancy\n* Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation\n* Gestational age at 16+0- 24+0 weeks\n\nExclusion Criteria:\n\nA potential paticipant who meets any of the following criteria will be excluded from participation in this trial:\n\n* Women with twin pregnancy in which one or both fetuses are diagnosed with a major structural or congenital abnormality that is likely to influence the composite adverse neonatal outcome.\n* Women with a monochorionic monoamniotic twin pregnancy\n* A monochorionic twin pregnancy with twin-to-twin transfusion syndrome before or at the time of inclusion.\n* Patients have indications for vaginal cerclage: Recurrent late miscarriage (from 14 weeks) or preterm birth occurring two or more times.\n* Women with dilatation of the cervix diagnosed by ultrasound or physical exam\n* Women with overt symptoms of preterm labor at the time of measurement of the short cervix (regular contractions, PPROM, recurrent blood loss).\n* Women with the presence of fever ≥ 38 degrees Celsius.\n* Women with a placenta previa, vasa previa.\n* Uterine malformations: unicornuate uterus, bicornuate uterus, uterine septum, fibroid…\n* Severe maternal conditions (heart failure, chronic kidney disease, systemic lupus erythematosus …)","FEMALE","18 Years",{"count":211,"type":23},260,[26],"This study aims to compare the effectiveness of cervical cerclage combined with progesterone versus progesterone alone in preventing preterm birth among women with twin pregnancies and a short cervix (cervical length ≤ 30 mm). Participants will be randomly allocated to either the intervention group (cerclage plus progesterone) or the control group (progesterone alone).",[29],[216,217,218],"Twin pregnancy","cervical cerclage","Progesterone","2026-04-23",{"date":191,"type":38},{"date":222,"type":23},"2026-04-10",{"date":224,"type":23},"2029-05-30",{"name":226,"class":45},"National Hospital of Obstetrics and Gynecology",6,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":141,"sex":18,"minAge":19,"maxAge":112,"enrollmentInfo":236,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":238,"conditions":239,"keywords":246,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":75},"100565751","neodoppler-new-ultrasound-technology-for-continuous-monitoring-of-cerebral-circulation-pilot-100565751","NCT06646250","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants","CE-NeoDoppler","Inclusion Criteria:\n\n* Open fontanelle\n* Healthy preterm or term born neonates\n* Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection\u002Fsepsis\u002Fmeningitis\n* Neonates in need of procedures\n\nExclusion Criteria:\n\n* Caregivers not understanding\u002Fspeaking Norwegian or English\n* Caregivers not giving their consent",{"count":237,"type":23},180,"Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term\u002Fpremature infants and sick neonates. For many years, the ultrasound group in Trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. Several methods previously developed in this research group are today widely used in hospitals around the world. In this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. This technology was CE-certified in October 2022, and in this project the investigators will test the CE-certified version with the newest available approved software.",[29,240,241,242,243,244,245],"Patent Ductus Arteriosus","Sepsis","Asphyxia","Stroke","Pulmonary Hypertension","Congenital Heart Disease",[247,248,249,250],"Cerebral Doppler","Monitoring","Continuous","Neonate","2026-04-22",{"date":219,"type":38},{"date":254,"type":38},"2024-10-20",{"date":256,"type":23},"2029-12-31",{"name":258,"class":45},"St. Olavs Hospital",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":270,"conditions":271,"keywords":276,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100607733","health-related-quality-of-life-and-household-financial-and-wellbeing-impacts-of-prematurity-and-necrotising-enterocolitis-nec-100607733","NCT07192393","Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).","Quantifying the Household Impact on Patient-Reported Outcomes and Costs Associated With the Care of Preterm Babies With and Without Necrotising Enterocolitis (NEC): A Study Alongside the Withholding Enteral Feeds Around Blood Transfusion (WHEAT) Trial","PREM-IMPACT","Inclusion Criteria:\n\n* Preterm birth \\\u003C30 gestational weeks\n\nExclusion Criteria:\n\n* Parent(s) of a preterm baby who died of necrotising enterocolitis (NEC)\n* Parent(s) unwilling or unable to provide written informed consent\n* Parent(s) and sibling(s) unable to understand English.","30 Weeks",{"count":269,"type":23},90,"PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge. NEC is a serious bowel disease that can occur in premature babies, often requiring surgery and prolonged hospitalisation.\n\nThis study runs alongside the WHEAT International Trial, which investigates whether pausing or continuing milk feeds during blood transfusions affects the risk of NEC in very preterm babies. PREM-IMPACT acts as a nested economic evaluation of the WHEAT Trial, helping to understand whether different feeding practices around transfusion offer good value for money from both the NHS and family perspective.\n\nPREM-IMPACT will collect detailed data on babies' health-related quality of life, as well as the financial, emotional, and social impact on parents and siblings. Families are recruited from neonatal units when their baby is ready to go home and complete questionnaires at three timepoints: 1) just before discharge, 2) six months later, and 3) twelve months later. Questionnaires cover health, wellbeing, healthcare use, and costs to the family (such as travel, time off work, or extra care needs). A dedicated research nurse based at the lead NHS site helps coordinate follow-up centrally.\n\nBy studying families of babies with and without NEC, this project aims to clarify the burden of prematurity and NEC on infant outcomes and family wellbeing. The results will inform future policy decisions, including whether pausing or continuing milk feeds during transfusion should be adopted in routine neonatal care.",[158,272,273,29,274,275],"Prematurity; Decision Support","Necrotising Enterocolitis","Preterm Birth","Preterm Infant Health",[277,278,279,280,281,165,29,282,283,284],"NEC","Cost-Effectiveness Analysis","Cost-Utility Analysis","Health-Related Quality of Life","HR-QoL","Health Economic Analysis","Financial Impact","Wellbeing","2026-03-27",{"date":287,"type":38},"2026-03-30",{"date":289,"type":38},"2025-08-08",{"date":291,"type":23},"2027-10-31",{"name":293,"class":45},"Imperial College London",7,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":303,"enrollmentInfo":304,"targetDuration":306,"studyType":147,"phases":4,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":322},"100597659","the-use-of-the-bambi-belt-in-exteremly-preterm-infants-an-implementation-study-100597659","NCT07061366","The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.","The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study","BB-EP","Inclusion Criteria: Preterm born \\\u003C26 weeks; first week of life -\n\nExclusion Criteria: skin integrity problems prior to study, palliative care.\n\n\\-","1 Week",{"count":305,"type":23},15,"1 Month","This observational, non-interventional cohort study evaluates the clinical use of the Bambi Belt-a CE-certified, wireless device for non-invasive heart rate and respiration monitoring-in extremely preterm infants (\\\u003C26 weeks gestation). 15 infants with intact skin and age \\\u003C24 hours will be monitored using the Bambi Belt during the first ten days of life. Primary outcomes include ease of use (application, signal stability), skin tolerance, and user experience (nurses and parents). Standard care remains unchanged. Data will be collected via clinical records and evaluation forms.",[29,248],[310,311,312],"wireless","monitoring","heart rate","2026-03-09",{"date":315,"type":38},"2026-03-11",{"date":317,"type":38},"2025-08-10",{"date":319,"type":23},"2027-01-01",{"name":321,"class":45},"Maxima Medical Center",2,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":331,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":24,"phases":335,"briefSummary":336,"conditions":337,"keywords":341,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":322},"100462841","an-exploratory-study-of-arginine-supplementation-and-the-postoperative-immune-response-100462841","NCT05306925","An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse","An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n* Preterm infants born \\\u003C30 weeks gestation requiring laparotomy\u002Fmajor bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge\n* Term and near term infants (born\\>35 weeks gestation) requiring laparotomy\u002Fmajor bowel surgery in the first 3 days of life (gastroschisis; major bowel atresias expected to require at least 7 days of PN)\n\nExclusion Criteria:\n\n* Infants who are unlikely to survive because of poor immediate postoperative condition\n* Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction\n* Parents who are unable to give informed consent","22 Weeks","44 Weeks",{"count":334,"type":23},48,[26],"ASPIRE is a nutrition study focusing on the effect of arginine supplementation on immune function in postoperative infants.\n\nThe investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term\u002Fnear term infants. 16 of these infants (8 preterm and 8 term\u002Fnear term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative infants\n\nThe investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.",[29,338,339,340],"Surgery","Nutritional Deficiency","Immune System and Related Disorders",[250,342,343,344,345],"Arginine","Postoperative","Immune function","Nutrition","2026-02-17",{"date":348,"type":38},"2026-02-18",{"date":350,"type":38},"2022-04-14",{"date":352,"type":23},"2026-12-31",{"name":354,"class":45},"University of Liverpool",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":141,"sex":18,"minAge":363,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":24,"phases":366,"briefSummary":367,"conditions":368,"keywords":371,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":75},"100575054","i-interact-preterm-parenting-100575054","NCT06767293","I-InTERACT Preterm Parenting","I-InTERACT Preterm Parenting Randomized Controlled Trial","I2P-RCT","Inclusion Criteria:\n\n* Born at \\\u003C 32 weeks gestational age.\n* Total T score of \\> 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of \\> 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale.\n* English is the primary spoken language in the home.\n\nExclusion Criteria:\n\n* Is not 18 years or older.\n* Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings).\n* English is not the primary language spoken in the home.\n* Caregivers with a psychiatric hospitalization in the past year.","3 Years","8 Years",{"count":269,"type":23},[26],"Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.",[369,29,62,370],"Child Behavior Problem","Parenting",[372,373,374],"telehealth","online learning","microlearning","2026-02-05",{"date":377,"type":38},"2026-02-09",{"date":379,"type":38},"2024-11-27",{"date":381,"type":23},"2027-09-30",{"name":383,"class":45},"Children's Hospital Medical Center, Cincinnati",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":141,"sex":18,"minAge":4,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":24,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":322},"100623397","efficacy-of-pimun-by-reducing-intermittent-hypoxia-events-100623397","NCT07396103","Efficacy of PIMUN by Reducing Intermittent Hypoxia Events","Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept","Inclusion Criteria:\n\n* Preterm infants with a gestational age at birth \\\u003C34 weeks\n* Age \\\u003C30 days at the time of enrollment\n* Documented diagnosis of apnea of prematurity (AOP)\n\nExclusion Criteria:\n\n* Currently receiving mechanical ventilation (MV)\n* Presence of major congenital malformations\n* Clinically unstable or critically ill at the time of screening\n* Active sepsis or undergoing treatment for sepsis\n* Intraventricular hemorrhage (IVH) Grade \\> II\n* Receiving sedatives or anticonvulsant medications","30 Days",{"count":393,"type":23},20,[26],"The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are:\n\nDoes PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN).\n\nParticipants will:\n\nUse\u002F or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.",[29,397,398],"Apnea of Prematurity","Hypoxemia","2026-02-03",{"date":377,"type":38},{"date":402,"type":38},"2024-09-01",{"date":404,"type":23},"2026-05-31",{"name":406,"class":45},"Pontificia Universidad Catolica de Chile",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":141,"sex":18,"minAge":55,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":24,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":430,"leadSponsor":432,"locationsCount":75},"100598214","effect-of-maternal-voice-on-physiological-indicators-and-feeding-performance-100598214","NCT07068581","Effect of Maternal Voice on Physiological Indicators and Feeding Performance","Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants born at gestational age ≥28 weeks and ≤34 weeks\n* Infants who are ≥30 postmenstrual weeks old at the time of enrollment\n* Infants weighing ≥1000 grams at the time of enrollment\n* Mothers aged 18 years or older\n* Preterm infants who have passed the hearing screening test\n* Infants whose mothers can provide an average of at least 30 ml of expressed breast milk daily during the study period.\n* Mothers who are Turkish speakers.\n* Infants for whom the decision to transition from enteral feeding to full oral feeding has been made for the first time jointly by the physician and nurse\n\nExclusion Criteria:\n\n* Preterm infants with congenital anomalies.\n* Infants with a family history of congenital hearing loss.\n* Infants diagnosed with intraventricular hemorrhage (grade 3-4) or -periventricular leukomalacia.\n* Infants who have had necrotizing enterocolitis requiring treatment.\n* Infants whose mothers have a history of substance abuse or alcoholism","28 Days",{"count":416,"type":23},50,[26],"This study aimed to determine the effect of maternal voice on physiological indicators and oral feeding performance in preterm infants.\n\nHypothesis 1 (H1): Preterm infants who listen to their mother's voice throughout the full oral feeding process have higher oxygen saturation levels than those who do not.\n\nHypothesis 2 (H2): Preterm infants who listen to their mother's voice throughout the full oral feeding process have lower heart rates than those who do not.\n\nHypothesis 3 (H3): Preterm infants exposed to maternal voice throughout the full oral feeding process have lower respiratory rates than those who are not exposed.\n\nHypothesis 4 (H4): Preterm infants exposed to maternal voice throughout the full oral feeding process have better feeding maturation than those who are not exposed.\n\nHypothesis 5 (H5): The percentage of nutrient intake in preterm infants exposed to maternal voice throughout the entire oral feeding process is higher than in those not exposed.\n\nHypothesis 6 (H6): The feeding time of preterm infants exposed to the mother's voice throughout the entire oral feeding process is shorter than that of those not exposed.\n\nHypothesis 7 (H7): The amount of food consumed per minute by preterm infants exposed to the mother's voice throughout the entire oral feeding process is greater than that of those not exposed.",[29,420],"Oral Feeding Performance",[422,423,424,425],"Preterm infants","Oral feeding performance","Maternal voice","NICU care","2025-12-11",{"date":428,"type":38},"2025-12-18",{"date":317,"type":38},{"date":431,"type":23},"2026-07-23",{"name":433,"class":45},"Acibadem University",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":141,"sex":18,"minAge":142,"maxAge":414,"enrollmentInfo":441,"targetDuration":4,"studyType":24,"phases":443,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":75},"100613951","feeding-maturity-in-preterm-infants-100613951","NCT07273266","Feeding Maturity in Preterm Infants","The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants","Inclusion Criteria:\n\n* Preterm\n* who are clinically stable, and\n* who are within the first day of initiating enteral feeding.\n\nExclusion Criteria:\n\n* Newborns who have a contraindication to pacifier use\n* have comorbid medical conditions\n* who are intubated\n* have congenital anomalies",{"count":442,"type":23},62,[26],"The aim of this study is to evaluate the effect of two pacifier-use strategies-routine 5-minute pacifier use prior to each feeding versus random 30-minute pacifier use at any time of day, independent of feeding-on feeding maturity in preterm infants. The hypotheses of the study are as follows: H1: The routine use of a pacifier prior to feeding has a positive effect on feeding maturity in preterm infants.\n\nH2: The routine use of a pacifier prior to feeding has a positive effect on discharge weight in preterm infants.\n\nH3: The routine use of a pacifier prior to feeding has a positive effect on the length of hospital stay in preterm infants.\n\nH4: The routine use of a pacifier prior to feeding has a positive effect on the gestational age at discharge in preterm infants.",[29,446,447],"Feeding","Non Nutritive Sucking",[449,450,451,452],"preterm","feeding","non nutritive sucking","feeding maturation","2025-12-07",{"date":455,"type":38},"2025-12-09",{"date":457,"type":38},"2025-03-04",{"date":459,"type":23},"2026-07-30",{"name":433,"class":45},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":468,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":75},"100342291","high-frequency-oscillation-ventilation-versus-conventional-mechanical-ventilation-in-very-preterm-infants-with-perinatal-acute-respiratory-distress-syndrome-multicenters-randomized-controlled-superiority-trial-100342291","NCT03736707","High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial","HFOV for ARDS","Inclusion criteria\n\n1. GA was between 24+0 and 31+6 weeks.\n2. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.\n3. Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \\> 7.20, PaCO2 60 mmHg, tidal volume of 5 ml\u002Fkg and \\> 35% of hematocrit (these may be evaluated by arterial blood gas analysis).\n\nExclusion criteria\n\nNeonates were not included if any of the following criteria were met:\n\n1. Parents or guardians' decision not to participate.\n2. Major congenital anomalies or chromosomal abnormalities\n3. Need for surgery or more than grade 2nd of IVH before randomization.","1 Minute","1 Hour",{"count":471,"type":23},400,[26],"Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.",[475,476,29,477],"Acute Respiratory Distress Syndrome","High Frequency Oscillatory Ventilation","Conventional Mechanical Ventilation","2025-09-30",{"date":480,"type":38},"2025-10-06",{"date":482,"type":23},"2025-10-01",{"date":72,"type":23},{"name":485,"class":45},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":493,"maxAge":494,"enrollmentInfo":495,"targetDuration":4,"studyType":24,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":75},"100608457","effects-of-early-physiotherapy-on-motor-optimality-score-in-at-risk-of-infants-100608457","NCT07201805","Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants","Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants: A Double-Blind Randomized Controlled Study","Inclusion Criteria:\n\n* Infants diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD, and those receiving oxygen or mechanical ventilation (MV) support\n* Infants with a 5-minute Apgar score \\\u003C3, \\\u003C37 weeks' gestation, \\\u003C1500 grams of preterm birth, or prematurity due to multiple births.\n* Infants with the corrected age of 2 to 4 months\n\nExclusion Criteria:\n\n* Infants with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)","2 Months","5 Months",{"count":416,"type":23},[26],"Medical and technological advances in neonatal care have led to a decrease in neonatal mortality and an increase in the survival of very low birth weight infants, leading to a global increase in the prevalence of cerebral palsy (CP), cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Early diagnosis and intervention programs have been established to meet the developmental needs of these at-risk infants in the neonatal intensive care unit (NICU). The goal of these programs is to facilitate the development of at-risk infants and normalize their motor, cognitive, and sensory development.Research remains unclear about which interventions are more effective when implemented. It is known that early intervention improves motor development in these infants, and that programs that include parents have more positive long-term outcomes for the cognitive and language development of at-risk infants.General Movements (GMs) are spontaneous movements that occur from the fetal period to 18 weeks postterm. Prechtl's General Movements Assessment (GMA) is a reliable tool for functional assessment of the young central nervous system.The assessment of motor repertoire (via the motor optimality score, MOS) describes the quality and quantity of the concurrent motor repertoire recorded during the GM assessment.The revised motor optimality score (MOS-R) has the potential to increase the prediction of adverse neurodevelopmental outcomes. It is noteworthy that the literature contains limited studies examining the effect of early physiotherapy applied to at-risk infants after NICU discharge on MOS-R. Therefore, the aim of this planned study was to investigate the effect of early family collaborative physiotherapy approaches applied to at-risk infants after NICU discharge on GMs MOS-R. Another aim was to determine the effect of early physiotherapy on neurological examination, cognitive, and language development in infants at 3 and 6 months of age and to compare them with similar peers receiving a routine treatment protocol.",[499,29,500,501],"Infants Admitted to Neonatal Units","Physiotherapy and Rehabilitation","Family Centered","2025-09-23",{"date":482,"type":38},{"date":505,"type":38},"2025-09-01",{"date":507,"type":23},"2026-10-30",{"name":509,"class":45},"Kahramanmaras Sutcu Imam University",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":528,"locationsCount":75},"100604000","a-national-multicenter-survey-on-small-vulnerable-newborns-100604000","NCT07143825","A National Multicenter Survey on Small Vulnerable Newborns","A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China","Inclusion Criteria:\n\n1. Newborns diagnosed as vulnerable infants at the participating hospitals between January 1 and December 31, 2024;\n2. Meeting any one of the following criteria:\n\n   * Diagnosed as small for gestational age (SGA): birth weight below the 10th percentile for infants of the same gestational age and sex;\n   * Preterm infants: gestational age less than 37 weeks;\n   * Low Birth Weight (LBW) infants: birth weight less than 2,500 grams.\n\nExclusion Criteria:\n\n* Incomplete medical records due to missing data preventing comprehensive case evaluation.",{"count":518,"type":23},2000,"The goal of this nationwide multicenter observational study is to comprehensively investigate the severity of Small Vulnerable Newborns (SVN) issues across China and to propose further preventive and intervention measures. The primary aim is to provide a thorough description of SVN problems using a unified definition and framework, and to develop targeted prevention strategies.\n\nParticipating centers across the country will collect clinical data on vulnerable newborns under their care and complete detailed questionnaires to support this research.",[29,521],"Small Gestational Age (SGA)","2025-08-19",{"date":524,"type":38},"2025-08-27",{"date":526,"type":38},"2025-04-01",{"date":352,"type":23},{"name":529,"class":45},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":24,"phases":541,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":75},"100603952","phase-2-precision-dosing-of-oral-ibuprofen-for-pda-a-pilot-rct-100603952","NCT07143201","Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT","Model Informed Precision Dosing of Oral Ibuprofen for Treatment of Persistent Patent Ductus Arteriosus: A Pilot Randomized Controlled Feasibility Trial","MIPD-PDA","Inclusion Criteria:\n\n* Neonates with a gestational age of ≤27+6 weeks\n* Admitted to the neonatal intensive care unit (NICU) at McMaster Children's Hospital (MCH)\n* Diagnosed with PDA in need of treatment based on targeted neonatal echocardiography (TnEcho) performed prior to 27+6 CGA or postnatal age of 3 days, whichever comes later.\n* Obtained parental consent.\n\nExclusion Criteria:\n\n* Major congenital or genetic abnormalities\n* Evidence for clinical or biochemical hepatic or renal failure (AST \\> 225 U\u002FL, ALT \\> 150 U\u002FL, or serum creatinine \\> 130 µmol\u002FL)\n* Sepsis - as defined by confirmed uncontrolled\u002Factive sepsis which will preclude any treatment of PDA\n* Contraindications to receive oral ibuprofen:\n* Severe hyperbilirubinemia in need for exchange transfusion\n* Severe feeding intolerance\n* Necrotizing enterocolitis (NEC)\n* Gastrointestinal perforation\n* Active bleeding\n* Severe thrombocytopenia (\\\u003C 50× 109\u002FL)","28 Weeks",{"count":540,"type":23},26,[542],"PHASE2","Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even death if it remains open and large. When closure of PDA is needed, doctors make every attempt to do it as soon as possible. Ibuprofen is the best drug to close the PDA, but it only works for 50% of small newborns. The investigators have shown before that small newborns handle ibuprofen differently and the amount of active ibuprofen that reaches their blood can be very unpredictable. Studies have shown if enough ibuprofen reaches the body, it can close the PDA. Therefore the investigators designed this study to see whether it is possible to give each newborn the right amount of ibuprofen that their body needs to close the PDA. The investigators will compare two ways to give ibuprofen in a small number of newborns: 1 - standard amount of ibuprofen to everyone, which is the usual care or 2 - ibuprofen doses that will be changed based on how much active ibuprofen has reached the body and how well the newborn's PDA is closing. The investigators will then compare the number of PDAs closed in each group and closely monitor any possible challenges for this new practice. By doing this project, the goals can be summarized as below:\n\nA. Primary goal: To determine if it is feasible to successfully run a larger study in the future.\n\nB. Secondary goals\n\n1. To assess how well and how safely the personalized (MIPD) method works, using a tool called WAPPS-PDA to guide dosing.\n2. To compare the effectiveness and safety of the personalized method with standard ibuprofen dosing.\n3. To identify drug levels in the blood (Cmin, AUC0-24, AUC0-72) that are associated with complete, partial, or no response to treatment.",[240,29],[536,546,547,548],"PDA","Precision Dosing","Ibuprofen",{"date":524,"type":38},{"date":551,"type":38},"2024-07-04",{"date":553,"type":23},"2027-07",{"name":555,"class":45},"Hamilton Health Sciences Corporation",{"id":557,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":558,"targetDuration":4,"studyType":24,"phases":559,"briefSummary":27,"conditions":560,"keywords":561,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":566,"leadSponsor":568,"locationsCount":46},"100534583",{"count":22,"type":23},[26],[29,30],[29,32,33],"2025-07-08",{"date":564,"type":38},"2025-07-11",{"date":40,"type":38},{"date":567,"type":23},"2026-12-30",{"name":44,"class":45},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":208,"minAge":4,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":4},"100585775","preterm-rupture-of-membranes-optimising-antibiotics-trial-100585775","NCT06906757","Preterm Rupture of Membranes Optimising Antibiotics Trial","Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.","PROMOAT","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nPregnant women and people who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for PROMOAT-specific eligibility.\n\nPROMOAT-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all PROMOAT-specific inclusion criteria:\n\n1. Women with singleton or multiple pregnancies complicated by preterm prelabour rupture of membranes (PPROM) \\\u003C 37+0 weeks' gestation as determined by the treating clinician and standard criteria:\n\n   * Maternal history consistent with loss of fluid per vagina\n   * Evidence of a pool of fluid in the vagina on sterile speculum examination\n   * +\u002F- positive testing for IGFBP-1 (Actim PROM) or PAMG-1 (Amnisure) AND\n2. Are eligible for at least two treatment arms within the domain\n3. The fetus\u002Ffetuses are alive at randomisation\n4. The pregnancy is continuing and active neonatal management is planned.\n\nParticipants will be excluded from participation if they meet core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves OR\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nParticipants will be excluded from participation if they meet any PROMOAT-specific exclusion criteria:\n\n1. Antibiotic treatment for \\> 24 hours administered with the aim of preventing infection from PPROM\n2. Suspected maternal or fetal infection (chorioamnionitis)\n3. Maternal or fetal indication for immediate birth\n4. Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)\n5. No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection\u002Fs\n6. Women with a previous infant affected by GBS sepsis\n7. Major congenital fetal anomaly.\n\nPlatform-eligible participants who meet all PROMOAT-specific inclusion criteria and none of the PROMOAT-specific exclusion criteria will be eligible to participate in PROMOAT.",{"count":578,"type":23},3900,[26],"The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.\n\nPROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM \\\u003C 37+0 weeks' gestation.\n\nResearchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.\n\nParticipants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.\n\nNeonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.\n\nQuestionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[582,29],"PPROM",[584,585],"Pregnancy, Preterm, PPROM, Antibiotics","chorioamnionitis","2025-03-31",{"date":588,"type":38},"2025-04-02",{"date":590,"type":23},"2025-09",{"date":592,"type":23},"2050-12",{"name":594,"class":45},"University of Melbourne",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":141,"sex":18,"minAge":538,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":75},"100580073","the-effect-of-surgical-incision-drep-use-in-endotracheal-tube-fixation-100580073","NCT06832553","The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation","The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants between 28-34 weeks of gestation hospitalized in neonatal intensive care unit,\n* Intubated infants on invasive mechanical ventilators,\n* Babies who were orally intubated were included in the study.\n\nExclusion Criteria:\n\n* Congenital skin condition,\n* With circulatory problems,\n* Congenital anomalies and metabolic disorders,\n* Small for gestational age (SGA) and large for gestational age (LGA),\n* Unplanned extubation taking place,\n* Babies intubated for less than 24 hours will be excluded from the study.","34 Weeks",{"count":604,"type":23},110,[26],"It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to these events. In addition, it is aimed to evaluate the relationship between these parameters by using devices measuring skin moisture, skin pH and Neonatal Skin Condition Assessment Scale in experimental and control groups.",[29],[449],"2025-03-11",{"date":611,"type":38},"2025-03-14",{"date":613,"type":38},"2024-10-15",{"date":615,"type":23},"2025-07-15",{"name":617,"class":45},"Hasan Kalyoncu University",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":141,"sex":18,"minAge":626,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":75},"100573988","co-regulation-and-interaction-in-the-nicu-100573988","NCT06753435","Co-regulation and Interaction in the NICU","Development of the Premature Infant's Stress System. Focus on Parent-infant Co-regulation and Interaction","CORI","Inclusion Criteria:\n\n* Swedish- or English-speaking parents aged over 18, born in Europe, and their infants born between gestational weeks 30+0 and 34+6.\n\nExclusion Criteria:\n\n* Parents with conditions or taking medications affecting the hormone system. Additionally, infants with major malformations or complex care needs that impede interaction possibilities are excluded.","2 Days",{"count":628,"type":23},105,"Preterm infants are exposed to multiple stressors each day, posing a risk of toxic stress that can impact their developing brains during a critical period of sensitivity. Elevated levels of the stress hormone cortisol can impede neuronal connectivity and communication, thereby increasing the likelihood of cognitive impairment and behavioural problems. Synchronized social-emotional mother-infant interaction holds promise in buffering stress reactivity and mitigating long-term stress effects.\n\nOur previous research has shown that preterm infants exhibit higher baseline saliva cortisol levels than full-term infants, along with blunted cortisol reactivity to stressors, irregular cortisol circadian rhythms, and delayed cortisol co-regulation between mother and infant. Another potential stress marker is saliva alpha-amylase (α-amylase), which has garnered increasing interest in adult research. However, there remains a significant gap in the literature concerning saliva α-amylase as a stress marker in preterm infants, warranting further investigation. The overall aim is to study development and relationships between three systems of parent-infant synchrony in preterm infants and their parents and elucidate potential confounding factors for a synchronous correlation. This will be done in relation to standardised care procedures commonly performed in the neonatal intensive care unit.\n\nThis observational study will involve 35 families undergoing three video-recorded procedures in the NICU. Saliva will be collected from infants and both parents before and after each procedure so we can analyse co-regulation of cortisol and alpha-amylase. Parent-infant interaction will be analysed from the videos using validated scales.\n\nThis study will be the first to document biological co-regulation and social-emotional parent-infant interaction simultaneously involving preterm infants and both parents in the NICU setting. Such insights are pivotal for the future design and implementation of tailored nursing interventions aimed at early stress mitigation, thereby reducing the risk of stress-related consequences.",[29],[632,633,634],"Preterm infant","Stress system","Family",{"date":636,"type":38},"2025-03-07",{"date":638,"type":38},"2025-01-07",{"date":640,"type":23},"2031-12",{"name":642,"class":102},"Linkoeping University",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":141,"sex":18,"minAge":649,"maxAge":650,"enrollmentInfo":651,"targetDuration":4,"studyType":24,"phases":653,"briefSummary":654,"conditions":655,"keywords":658,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":75},"100499561","the-effect-of-touch-methods-on-pain-and-physiological-parameters-in-preterm-infants-during-endotracheal-aspiration-100499561","NCT05784857","The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration","Inclusion Criteria:\n\n* The gestational week of the infant is less than 38\n* Absence of congenital anomaly\n* Mechanical ventilator support\n* Absence of comorbid disease\n* Not having undergone surgery\n* No analgesic medication has been administered in the last hour\n\nExclusion Criteria:\n\n• Infants with diseases such as sepsis that interfere with the application of touch technique","24 Weeks","37 Weeks",{"count":652,"type":23},81,[26],"Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Correct stimulation of the infant's sense of touch affects psychosocial development positively. In addition, it is reported that touch has a calming and analgesic effect during invasive interventions. Therefore, there is a need for touch appropriate for development of newborn.\n\nThe aim of this study was determine the effect of Yakson and Gentle Human Touch on pain and physiologic parameters in preterm infants during endotracheal aspiration.",[29,656,657],"Pain","Infant ALL",[659,660,661],"touch","preterm infant","pain","2025-03-03",{"date":664,"type":38},"2025-03-05",{"date":666,"type":38},"2023-02-24",{"date":668,"type":23},"2025-07-01",{"name":433,"class":45},{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":4,"eligibilityCriteria":676,"healthyVolunteers":141,"sex":18,"minAge":469,"maxAge":677,"enrollmentInfo":678,"targetDuration":4,"studyType":24,"phases":680,"briefSummary":681,"conditions":682,"keywords":684,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":75},"100558369","evaluation-of-nasal-non-invasive-ventilation-in-management-of-neonates-with-respiratory-distress-using-lung-ultrasound-100558369","NCT06550219","Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound","Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound","Inclusion Criteria: Preterm \\\u003C37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).\n\nExclusion Criteria:\n\n1. Obvious major congenital abnormalities.\n2. Any of the baby intubated for resuscitation or for other reasons.\n3. Neonates need invasive mechanical ventilation.\n4. Pulmonary hemorrhage.\n5. Severe cardiovascular instability.\n6. Cardiopulmonary arrest needing prolonged resuscitation.\n7. Birth asphyxia (one-minute Apgar score ≤ 3).\n8. Major cardiac diseases (not including patent ductus arteriosus).","24 Hours",{"count":679,"type":23},30,[26],"This study aims to evaluate the effect of non-invasive ventilation (nIPPV)\n\n, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates \\\u003C37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay",[29,683],"Ventilator Lung; Newborn",[685,686],"preterm infants","non-invasive ventilation","2025-02-03",{"date":689,"type":38},"2025-02-04",{"date":691,"type":38},"2024-11-20",{"date":693,"type":23},"2025-11-01",{"name":695,"class":45},"Alexandria University"]