[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nicu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nicu":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,77,122,156,182],{"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":27,"conditions":28,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640398","phase-1-optimizing-preterm-infant-ampicillin-dosing-100640398",false,"NCT07610486","Optimizing PreTerm Infant Ampicillin Dosing","An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing","OPTI-Amp","Inclusion Criteria:\n\n* Documented informed consent from parent\u002Fguardian\n* Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)\n* less than or equal to 34 completed weeks gestational age (GA) at birth and \\\u003C 7 days of life at time of screening\n* Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis\n\nExclusion Criteria:\n\n* Infant on extracorporeal support (e.g., ECMO)\n* Positive blood culture or other confirmed infection\n* At time of consent, infants with GA \\\u003C28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received \\> 32 to 36 hours of ampicillin, depending on dosing regimen\n* Has major congenital abnormalities where survival to 30 days of life is not expected\n* Failure to obtain consent from parent\u002Fguardian\n* Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA\n* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","ALL","0 Days","7 Days",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are:\n\n* Does short-course ampicillin provide high enough levels of ampicillin at 48 hours?\n* Is short-course ampicillin safe for preterm infants to receive?\n\nPreterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin.\n\nParticipants will:\n\n* stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed)\n* have a blood sample collected around 48 hours from when they started ampicillin\n* have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner",[29,30,31,32,33],"Early Onset Sepsis","Preterm Neonates","NICU","Ampicillin","Safety and Pharmacokinetics","NOT_YET_RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-28","ACTUAL",{"date":40,"type":22},"2026-07",{"date":42,"type":22},"2027-12",{"name":44,"class":45},"Duke University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100630204","phase-4-a-study-to-compare-the-efficacy-and-safety-of-extended-and-intermittent-infusion-of-beta-lactams-in-critically-ill-paediatric-patients-100630204","NCT07484633","A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients","A Protocol of a Randomised, Two-arm Superiority Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients","PEBBLE","Inclusion Criteria:\n\n* paediatric patients (0-17 years of age) with suspected or confirmed bacterial infection who are treated in a PICU or NICU and diagnosed with sepsis with a total Phoenix Sepsis Score ≥2 points, and the infection is clinically probable or confirmed by microbiological culture (e.g. from a blood culture, cerebrospinal fluid, urine, trachea, wound, etc.), excluding contamination;\n* who are receiving β-lactams including meropenem, piperacillin\u002Ftazobactam, cefepime and ceftriaxone;\n* who received the same β-lactam therapy within 24 hours prior to inclusion or started new β-lactam therapy due to clinical deterioration;\n* written consent of the parent or guardian is obtained.\n\nExclusion Criteria:\n\n* palliative care patients;\n* patients participating in other drug trials;\n* patients with impaired renal function if dosing modification is required (estimated Glomerular Filtration Rate \\[eGFR\\]\\\u003C50 mL\u002Fmin\u002F1.73m2 for meropenem, cefepime, and piperacillin\u002Ftazobactam; eGFR\\\u003C10 mL\u002Fmin\u002F1.73m2 for ceftriaxone);\n* patients undergoing plasmapheresis (TPE);\n* patients undergoing extracorporeal therapy (continuous kidney replacement therapy \\[CKRT\\] or extracorporeal membrane oxygenation \\[ECMO\\]);\n* β-lactam allergy;\n* patients admitted from another institution or department who have been on the same β-lactam treatment for more than 24 hours;\n* pregnancy.","0 Hours","17 Years",{"count":58,"type":22},110,[60],"PHASE4","The goal of this clinical trial is to examine the success and safety of administering certain antibiotics (beta-lactams) given in a longer 3-hour infusion to children (0-17 years) who are critically ill and have severe infection.\n\nThe main question it aims to answer is:\n\nIs the longer infusion more effective than the conventional short-term (0.5-hour-long) infusion? Researchers will compare the 3-hour-long infusion group to the 0.5-hour-long infusion group to determine whether the longer infusion can cure the infection earlier and whether it is equally safe. The doses are the same in the two groups. Only the duration differs until the patient receives the antibiotic.\n\nParticipants will:\n\n* be given the required antibiotic drug in a 3-hour-long or in a 0.5 hour-long infusion.\n* be examined to make sure their blood drug levels are correct. This will require two blood tests.\n* be treated according to routine care and have examinations and blood tests performed.",[63,64,31,65,66],"Infection","Sepsis","PICU","Beta Lactams","2026-04-07",{"date":69,"type":38},"2026-04-13",{"date":71,"type":22},"2026-04",{"date":73,"type":22},"2028-04",{"name":75,"class":45},"Semmelweis University",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":103,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":46},"100619990","mindfulness-and-meditation-based-lactation-education-on-maternal-breastmilk-in-the-neonatal-icu-100619990","NCT07351799","Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU","The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study","Inclusion Criteria:\n\n* Maternal age \\> 20 years of age\n* Read, write and understand English\n* Infant NICU admit\n* Infant birthplace of Rochester, MN (Mayo Clinic)\n* Maternal adherence to pumping ≥ 8 times in 24 hours\n* Mother enrolled within 72 hours of birth\n* Gestational age of neonate at birth of \\\u003C 34 0\u002F7 weeks\n\nExclusion Criteria:\n\n* Maternal extensive existing mindfulness practice\n* Maternal breast\u002Fchest surgery\n* Maternal polycystic ovarian syndrome (PCOS)\n* Maternal current illicit substance abuse\n* Diagnosis of maternal current severe mental health concerns\n* Maternal multiple gestation (twins or higher order) pregnancy and delivery",true,"FEMALE","20 Years",{"count":88,"type":22},40,[90],"NA","The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.",[93,94,31,95,96,97,98,99,100,101,102],"Lactation","Mindfulness","Breastmilk","Neonatal","Meditation","Pumping, Breast","Cortisol","Oxytocin","Anxiety","Depression",[104,105,31,106,96,107,108,109,110,111,102],"lactation","mindfulness","breastmilk","meditation","pumping, breast","cortisol","oxytocin","anxiety","RECRUITING","2026-01-12",{"date":115,"type":38},"2026-01-20",{"date":117,"type":38},"2025-09-22",{"date":119,"type":22},"2026-11-02",{"name":121,"class":45},"Mayo Clinic",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":140,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":46},"100617754","the-effect-of-massage-on-sleep-quality-stress-comfort-and-vital-signs-in-preterm-infants-100617754","NCT07322731","The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants","The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants born between 35-37 weeks gestational age.\n* Admitted to the neonatal intensive care unit (NICU).\n* Medically stable and cleared for massage therapy by neonatologist.\n* Parental\u002Fguardian consent obtained.\n\nExclusion Criteria:\n\n* Infants with congenital anomalies or major medical complications.\n* Infants requiring mechanical ventilation or intensive respiratory support.\n* Infants with known neurological disorders.\n* Parental\u002Fguardian refusal or inability to participate.","35 Months","37 Months",{"count":88,"type":22},[90],"This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, while the control group will receive standard care. Data will be collected using the Premature Infant Comfort Scale, Neonatal Stress Scale, actigraphy for sleep monitoring, and vital sign measurements. The study aims to determine whether massage therapy can improve the overall well-being and development of preterm infants in NICU settings.",[135,136,137,138,139,31],"Premature Infants","Sleep Quality","İnfant Stress","İnfant Comfort","Vital Signs",[141,142,31,143,144,145,146],"Preterm infants","neonatal massage","sleep quality","stress reduction","comfort","vital signs","2025-12-22",{"date":149,"type":38},"2026-01-07",{"date":151,"type":38},"2025-08-15",{"date":153,"type":22},"2026-06-15",{"name":155,"class":45},"Yuzuncu Yil University",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":46},"100608456","effects-of-early-physiotherapy-program-on-the-infants-in-nicu-100608456","NCT07201792","Effects of Early Physiotherapy Program on the Infants in NICU","Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Newborns 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.\n* Newborns receiving oxygen or mechanical ventilation (MV) support.\n* Infants with a 5-minute Apgar score \\\u003C3, \\\u003C37 weeks' gestation, \\\u003C1500 g preterm, or prematurity due to multiple births.\n\nExclusion Criteria:\n\n* Newborns 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.)","28 Weeks","42 Weeks",{"count":166,"type":22},100,[90],"High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).",[170,31,171,172],"Infants Admitted to Neonatal Units","NICU Infants","Family Centered Care","2025-09-23",{"date":175,"type":38},"2025-10-01",{"date":177,"type":38},"2025-09-15",{"date":179,"type":22},"2026-08-30",{"name":181,"class":45},"Kahramanmaras Sutcu Imam University",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":46},"100589196","music-therapy-during-hypothermia-in-the-nicu-100589196","NCT06951269","Music Therapy During Hypothermia in the NICU","The Effect of Music Therapy on Pain Levels in Neonates With Hypoxic-ischemic Encephalopathy During Hypothermia: a Randomized Pilot and Feasibility Study","Inclusion Criteria:\n\n\\- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.\n\nExclusion Criteria:\n\n* Newborns with a gestational age of less than 35 weeks and a birth weight of less than 1800 grams.\n* Newborns in palliative care or with congenital anomalies with a poor prognosis will also be excluded, as will those with preexisting neurological or genetic conditions.\n* Furthermore, newborns with a history of serious medical complications that may influence participation in the study, such as pulmonary hypertension or secondary seizure syndrome, will be considered ineligible.\n* Finally, patients with an N-PASS score of less than -2 will be excluded.","35 Weeks","44 Weeks",{"count":192,"type":22},22,[90],"Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures.\n\nResearch question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings.\n\nExpected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.",[196,197,198,199,31,200],"Music Therapy","Pain","Allodynia","Neonates","Hypothermia Neonatal","2025-09-17",{"date":173,"type":38},{"date":204,"type":22},"2025-10-30",{"date":206,"type":22},"2027-08-01",{"name":208,"class":45},"Fundación Santa Fe de Bogota"]