[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-premature\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-premature":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,54,86,133,170,191,224,248,278,318,365,387],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100642471","phase-4-fentanyl-and-rocuronium-for-tracheal-intubation-in-newborns-100642471",false,"NCT07650552","Fentanyl and Rocuronium for Tracheal Intubation in Newborns","Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial","NEORIN","Inclusion Criteria:\n\n* Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age \\\u003C44 weeks\n* Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)\n* Informed consent signed by legal guardians\n\nExclusion Criteria:\n\n* Upper airway malformations\n* Use of neuromuscular blocking agent in the 24 hours prior to enrollment\n* Known hypersensitivity to fentanyl or rocuronium\n* Severe hemodynamic instability (ongoing shock)\n* Anticipated difficult airway (micrognathia, cleft palate, or similar)\n* Cyanotic congenital heart disease with critical instability\n* Neonatal abstinence syndrome\n* Concurrent enrollment in another interventional clinical trial","ALL","1 Minute","28 Days",{"count":21,"type":22},102,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates.\n\nThis randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg\u002Fkg IV) to standard fentanyl premedication (1 mcg\u002Fkg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg\u002Fkg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.\n\nA secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.",[28,29,30,31],"Infant, Premature","Intubation, Intratracheal","Respiratory Distress Syndrome, Newborn","Apnea of Prematurity",[33,34,35,36,37,38,39,40],"neonatal intubation","rocuronium","premedication","neuromuscular blocking agent","sugammadex","first-attempt success","NICU","newborn","NOT_YET_RECRUITING","2026-06-29",{"date":44,"type":45},"2026-07-01","ACTUAL",{"date":47,"type":22},"2026-09",{"date":49,"type":22},"2029-02",{"name":51,"class":52},"UEA - Universidade Do Estado Do Amazonas","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100058940","follow-up-visit-of-high-risk-infants-100058940","NCT00009633","Follow-up Visit of High Risk Infants","FU","* Infants inborn at NRN centers\n* \\\u003C27 weeks gestational age\n* Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and\u002For older than 27 weeks may be included in the FU Study.\n\nNote: These inclusion criteria were changed as of 1\u002F1\u002F2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.","18 Months","26 Months",{"count":64,"type":22},68000,"OBSERVATIONAL","The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.",[68,69,70,28],"Infant, Newborn","Infant, Low Birth Weight","Infant, Small for Gestational Age",[72,73,74,75,76],"NICHD Neonatal Research Network","Extremely Low Birth Weight (ELBW)","Prematurity","Neurodevelopmental Outcome","Follow up studies","RECRUITING",{"date":44,"type":45},{"date":80,"type":45},"1993-04-01",{"date":82,"type":22},"2030-03-31",{"name":72,"class":84},"NETWORK",31,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":99,"conditions":100,"keywords":108,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":53},"100601587","phase-1-fentanyl-intranasal-for-retinopathy-of-prematurity-screening-in-preterm-infants-100601587","NCT07112430","Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants","Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial","FIREFLY","Inclusion Criteria\n\n* Preterm infants born ≤31 weeks gestational age and\u002For with birth weight \\\u003C1250 g\n* Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care\n* Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support\n* Written informed consent obtained from a parent or legally authorized representative\n\nExclusion Criteria\n\n* Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration\n* Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative\u002Fanalgesic medications within 24 hours prior to the ROP examination\n* Known hypersensitivity or prior adverse reaction to fentanyl",{"count":95,"type":22},58,[97,98],"PHASE1","PHASE2","The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening.\n\nParticipants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.",[101,102,103,28,104,68,105,106,107],"Neonatal Pain","Retinopathy of Prematurity (ROP)","Pain Management","Fentanyl","Neonatal Intensive Care Units","Analgesia","Intranasal Drug Administration",[109,110,111,112,113,114,115,116,117,118,119,120,121,39,122,123],"intranasal fentanyl","fentanyl","neonatal analgesia","procedural pain","ROP screening","Retinopathy of Prematurity","Preterm infants","Premature infants","infant pain","Non-invasive analgesia","Opioid analgesia","Intranasal drug delivery","Neonatal intensive care","Pain management in neonates","Infant procedural sedation","2026-06-26",{"date":126,"type":45},"2026-06-30",{"date":128,"type":22},"2026-09-09",{"date":130,"type":22},"2028-06-01",{"name":132,"class":52},"Marsha Campbell-Yeo",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":141,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":4},"100640472","bed-rest-with-a-short-cervix-on-preterm-birth-100640472","NCT07577388","Bed Rest With a Short Cervix on Preterm Birth","BEWISE - Bed Rest With a Short Cervix on Preterm Birth","BEWISE","Pregnant women with gestational age 20+0 to 33+6\n\n* Cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies\n* Above 18 years of age\n* Reads and understands Danish or English","FEMALE","18 Years",{"count":144,"type":22},6000,[146],"NA","Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.\n\nThe use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects.\n\nThe overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR).\n\nThe primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix.\n\nSecondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density.\n\nThrough the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria.\n\nThe primary outcome is gestational age in days (continuous).",[149,150,151,152,153,154,155,28,156,157,158,159,160],"Preterm Birth","Cervical Insufficiency","Bed Rest","Pregnancy Complications","Immobilization","Depression, Postpartum","Pregnancy Outcome","Uterine Cervical Incompetence","Premature Birth","Obstetric Labor, Premature","Physical Activity","Bone Density","2026-05-03",{"date":163,"type":45},"2026-05-11",{"date":165,"type":22},"2026-05-01",{"date":167,"type":22},"2029-05-01",{"name":169,"class":52},"Julie Glavind",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":85},"100062628","generic-database-of-very-low-birth-weight-infants-100062628","NCT00063063","Generic Database of Very Low Birth Weight Infants","Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants","GDB","Inclusion Criteria:\n\n* Infants inborn at NICHD NRN centers that are:\n* 401-1000 grams birth weight, and\u002For\n* 20 0\u002F7 to 28 6\u002F7 weeks (\\\u003C29 weeks) gestational age\n* Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and\u002For older than 29 weeks may be included in the GDB.\n\nExclusion Criteria:\n\n* Infants \\>1,000 grams birth weight and\u002For \\>29 weeks gestational age\n\nNote: These inclusion criteria were changed as of 1\u002F1\u002F2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.","14 Days",{"count":180,"type":22},80000,"The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is \"generic\"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.",[68,69,70,28],[72,73,74],"2026-03-12",{"date":186,"type":45},"2026-03-16",{"date":188,"type":45},"1987-04-01",{"date":82,"type":22},{"name":72,"class":84},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":198,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":53},"100615630","personalized-music-therapy-for-preterm-infants-100615630","NCT07295106","Personalized Music Therapy for Preterm Infants","Evaluation of the Effects of Personalized Music Therapy on Preterm Infants Admitted to the Neonatal Intensive Care Unit (NICU) and on Parental Stress: A Pilot Randomized Crossover Controlled Trial","Inclusion Criteria:\n\n* Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment.\n* Gestational age at birth 28+0 to 36+6 weeks.\n* Age at enrollment: 5 to 15 days.\n* Stable vital signs at enrollment per unit policy.\n* Apgar score at 5 minutes ≥ 7.\n* Birth weight appropriate for gestational age, between the 50th and 90th percentile.\n* Written informed consent from parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n* Post-operative status at the time of enrollment.\n* One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia.\n* Congenital anomalies.\n* Hypersensitivity or intolerance to sound.\n* Maternal history of drug and\u002For alcohol misuse during pregnancy.\n* Lack of parental consent.","5 Days","15 Days",{"count":201,"type":22},20,[146],"Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.",[28,205],"Stress, Psychological",[207,39,208,209,210,211,212,213,214],"Neonatal Intensive Care Unit","Music Therapy","Parental Voice","Tissue Oxygenation Index (TOI)","Respiratory Rate","Near-Infrared Spectroscopy (NIRS)","Heart Rate","Oxygen Saturation","2025-12-16",{"date":217,"type":45},"2025-12-19",{"date":219,"type":45},"2025-10-13",{"date":221,"type":22},"2026-03",{"name":223,"class":52},"Fabrizio Faina",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":178,"maxAge":19,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100596955","phase-3-dexamethasone-regimens-for-bpd-prevention-in-preterm-infants-100596955","NCT07052201","Dexamethasone Regimens for BPD Prevention in Preterm Infants","The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial","Inclusion Criteria (Must meet ALL of the following)\n\n1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.\n2. FiO₂ \\> 40% and MAP \\> 8 cmH₂O (maintained for at least 24 hours prior to enrollment).\n3. Parent\u002FLegal guardian has provided signed informed consent.\n4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.\n\nExclusion Criteria (Will be excluded if they meet ANY of the following)\n\n1. Presence of ventilator-associated pneumonia at the time of enrollment.\n2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.\n3. Suffering from other severe life-threatening illnesses with a short-expected survival time.\n4. Parent\u002FLegal guardian refuses to participate in the study.",{"count":232,"type":22},970,[234],"PHASE3","The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age?\n\nResearchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer.\n\nParticipants will:\n\nInclusion Criteria (Must meet ALL of the following)\n\n1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.\n2. FiO₂ \\> 40% and MAP \\> 8 cmH₂O (maintained for at least 24 hours prior to enrollment).\n3. Parent\u002FLegal guardian has provided signed informed consent.\n4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.\n\n2\\. Exclusion Criteria (Will be excluded if they meet ANY of the following)\n\n1. Presence of ventilator-associated pneumonia at the time of enrollment.\n2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.\n3. Suffering from other severe life-threatening illnesses with a short-expected survival time.\n4. Parent\u002FLegal guardian refuses to participate in the study.",[28,237],"Bronchopulmonary Dysplasia (BPD)","2025-11-19",{"date":240,"type":45},"2025-11-24",{"date":242,"type":22},"2026-02-01",{"date":244,"type":22},"2028-05-31",{"name":246,"class":52},"The Children's Hospital of Zhejiang University School of Medicine",24,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":256,"sex":17,"minAge":257,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":53},"100596434","effect-of-developmental-care-on-comfort-growth-and-oral-feeding-transition-in-preterm-infants-100596434","NCT07045402","Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants","The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants","KCareInfant","Inclusion Criteria:\n\n1. Infants with a gestational age between 30-34 weeks.\n2. The mother's ability to read and write.\n3. The infant must be fully enterally fed at the time of enrollment in the study.\n4. Infants who are being fed via orogastric tube at the time of enrollment.\n5. Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.\n6. Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied.\n\nExclusion Criteria:\n\n1. Presence of a congenital anomaly or genetic disease.\n2. Requirement of ventilator support.\n3. Infants receiving antibiotics for sepsis or suspected sepsis.\n4. Administration of sedative treatment.\n5. Having an intracranial hemorrhage greater than grade II.\n6. The mother having a physical condition that prevents skin-to-skin contact.\n7. The mother using substances or alcohol.",true,"30 Weeks","34 Weeks",{"count":260,"type":22},68,[146],"This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.",[28,264,265,266,267,268],"Kangaroo Mother Care","Comfort","Feeding","Oral Feeding Performance","Facilitated Tucking","2025-09-03",{"date":271,"type":45},"2025-09-04",{"date":273,"type":45},"2025-02-10",{"date":275,"type":22},"2026-03-10",{"name":277,"class":52},"Fenerbahce University",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":285,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":289,"conditions":290,"keywords":300,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100601977","heterogeneity-index-in-neonatologist-performed-lung-ultrasound-in-neonates-receiving-respiratory-support---a-pilot-study-100601977","NCT07117513","Heterogeneity Index in Neonatologist-performed Lung Ultrasound in Neonates Receiving Respiratory Support - a Pilot Study","NPLUS HI","Inclusion Criteria:\n\n* Preterm neonates born between 28+0 and 36+6 weeks of gestation and term-born neonates (\\> 37+0 weeks of gestation) admitted to the NICU\n* Presence of respiratory distress requiring respiratory support (invasive and non-invasive) at the timepoint of NPLUS 1.\n* Written informed consent obtained from the parents prior to the measurement.\n\nExclusion Criteria:\n\n* cardiopulmonary malformations\n* pleural effusion\n* pneumothorax","1 Hour","7 Days",{"count":288,"type":22},40,"Lung ultrasound is an increasingly valuable diagnostic tool in neonatal intensive care due to its safety and accessability.\n\nThis pilot study investigates whether a quantitative approach - the heterogeneity index, previously only used in fetal lung assessment - can enhance the diagnostic accuracy of neonatologist-performed lung ultrasound (NPLUS). The index will be calculated from raw ultrasound images of preterm and term neonates and compared with conventional lung ultrasound scores to evaluate its clinical relevance.",[291,68,28,292,293,294,295,296,297,298,299],"Intensive Care Units, Neonatal","Point-of-Care Systems","Ultrasonography","Lung Ultrasound","Lung Ultrasound Score","Image Interpretation, Computer Assisted","Reproducibility of Results","Respiratory Distress Neonatal","Respiratory Support",[301,294,295,302,207,303,304,305,306,307,40],"Neonatologist-Performed Lung Ultrasound","Quantitative Lung Ultrasound","Observer Variability in Imaging","Ultrasound Artifact Interpretation","Respiratory Distress Syndrome in Neonates","respiratory support","preterm neonate","2025-08-05",{"date":310,"type":45},"2025-08-12",{"date":312,"type":22},"2025-08-15",{"date":314,"type":22},"2026-08-01",{"name":316,"class":52},"Medical University of Graz",2,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":256,"sex":17,"minAge":142,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":328,"conditions":329,"keywords":338,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":53},"100579648","global-survey-on-newborns-hospitalisation-and-parental-experiences---the-hope-study-100579648","NCT06827028","Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study","Global Survey on Newborns' HOspitalisation and Parental Experiences","HOPE","Inclusion Criteria:\n\nParent or caregiver of a newborn infant born on January 1, 2023, or thereafter, who received\u002Fis receiving special\u002Fintensive care starting within the first week of life such as oxygen therapy or other respiratory support, incubator treatment, intravenous infusions, treatment of (suspected) sepsis, pneumonia, necrotising enterocolitis, malformations, jaundice, nutritional\u002Ffeeding problems, hypoglycemia, etc.\n\nExclusion Criteria:\n\n* Other family members than parents\u002F(primary) caregivers\n* Parents of newborns that did not receive special\u002Fintensive care starting within the first week of life\n* Parents or caregivers of infants born before 1 January 2023\n* Persons with insufficient proficiency of one of the languages of the questionnaire",{"count":327,"type":22},100,"This study aims to explore parents' experiences and emotional burdens related to their newborn's hospital stay using an online survey. Our target population consists of parents of newborns born preterm, with low birthweight, or critically ill. Particularly the presence of infant- and family-centred developmental care (IFCDC) principles as well as support through political framework conditions will be investigated.",[28,69,330,331,332,333,334,205,335,336,337],"Parents","Life Change Events","Needs Assessment","Anxiety","Fear","Uncertainty","Emotions","Caregiver Burden",[339,340,341,342,39,343,344,345,346,332,347,330,68,348,349,350,351,352,353,354,355],"Parental needs","Infant- and Family-centred developmental care","IFCDC","EFCNI","Global Parent Survey","Breastfeeding","Breastfeeding support","Politics","HRQoL","Family","Family Support","Family Health","Intensive Care, Neonatal","Patient-Centered Care","Infant Care","Surveys and Questionnaires","Health Care Surveys","2025-04-24",{"date":358,"type":45},"2025-04-27",{"date":360,"type":22},"2025-09-01",{"date":362,"type":22},"2027-12-31",{"name":364,"class":52},"Global Foundation for the Care of Newborn Infants",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":256,"sex":17,"minAge":4,"maxAge":286,"enrollmentInfo":372,"targetDuration":374,"studyType":65,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":53},"100571897","extremely-preterm-respiratory-outcome-cohort-100571897","NCT06726226","Extremely Preterm Respiratory Outcome Cohort","Multicenter Cohort for Respiratory Outcome of Preterm Infants","Inclusion Criteria:\n\n* Infants born at gestational age less than 29 weeks with cohort consent obtained within 7 days of birth\n\nExclusion Criteria:\n\n* death within 3 days of birth\n* severe structural heart defects\n* structural abnormalities in the upper airway, lungs, or chest\n* congenital anomalies that may impact cardiopulmonary function\n* follow-up is difficult until 24 months of age",{"count":373,"type":22},600,"6 Years","This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary dysplasia, postnatal corticosteroids, ventilatory support, as well as nutritional aspect during NICU stay. Furthermore, it scrutinizes the incidence of chronic respiratory diseases stemming from these conditions, assessing their long-term impact on respiratory prognosis post-discharge. In addition to respiratory aspects, the research extends its focus to the growth and developmental outcomes of preterm infants. By synthesizing these multifaceted elements, the study aspires to enhance current treatments and preventative measures for respiratory conditions in preterm infants.",[28,377],"Respiratory Disease","2024-12-04",{"date":380,"type":45},"2024-12-10",{"date":382,"type":45},"2022-06-01",{"date":384,"type":22},"2030-02-28",{"name":386,"class":52},"Seoul National University Hospital",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":4},"100563224","effects-of-an-information-based-discharge-service-on-preterm-infants-parents-and-hospitals-100563224","NCT06613386","Effects of an Information-Based Discharge Service on Preterm Infants, Parents, and Hospitals","The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant, Parent, and Hospital: a Randomized Controlled Trial","Inclusion Criteria for Infants:\n\n* Infants with a gestational age of less than 37 weeks at birth.\n* Written informed consent obtained from legal guardians.\n* Neonates delivered at the study hospital or transferred within the first 24 hours of life.\n\nExclusion Criteria for Infants:\n\n* Presence of major life-threatening congenital anomalies.\n* Critical illness or conditions requiring immediate intensive intervention.\n* Significant developmental abnormalities, including but not limited to severe congenital malformations, metabolic disorders, or central nervous system anomalies.\n\nRemoval Criteria for Infants:\n\n* Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.\n\nInclusion Criteria for Parents:\n\n* Parents of infants born at less than 37 weeks of gestational age.\n* Written informed consent provided by the parents.\n* Ability to dedicate at least 4 hours per day to infant care.\n* Adequate reading comprehension and proficiency in using electronic devices.\n* If multiple caregivers are involved, the primary caregiver with the most hours of caregiving will be selected.\n\nExclusion Criteria for Parents:\n\n* Health, familial, social, or language barriers that impair effective integration into the healthcare team.\n\nRemoval Criteria for Parents:\n\n* Voluntary withdrawal from the study.\n* Non-compliance with study protocols.","37 Weeks",{"count":396,"type":22},86,[146],"Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied.\n\nObjective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs.\n\nDesign: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China.\n\nParticipants: Preterm infants and their parents.\n\nMethods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.",[400,28],"Patient Discharge","2024-09-23",{"date":403,"type":45},"2024-09-26",{"date":405,"type":22},"2024-10",{"date":407,"type":22},"2025-03",{"name":409,"class":52},"The First Affiliated Hospital with Nanjing Medical University"]