[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-infants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-infants":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,74,102,131,166,197,227,252],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100641078","the-impact-of-masseter-muscle-thickness-on-the-feeding-process-in-preterm-infants-in-ultrasound-assessment-100641078",false,"NCT07656467","The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment","The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment - an Observational Study","Inclusion Criteria:\n\n* 28+0\u002F7-32+0\u002F7 weeks of gestational age;\n* use of one specific type of teat;\n* passive oxygen therapy is permitted;\n* written informed consent obtained from parents.\n\nExclusion Criteria:\n\n* newborns with defects that may significantly affect the development of feeding function such as: cleft lip and\u002For palate, facial paralysis, and other craniofacial defects;\n* newborns with a shortened anterior lingual frenulum according to the E. Coryllos classification - meeting the criteria for frenotomy according to the Hazelbaker\u002FAmir scale;\n* detected genetic defects, metabolic diseases, or suspected cases of their presence;\n* newborns requiring intubation up to 10 days of life;\n* low Apgar score (less than 5 points at 5 and 10 minutes of life);\n* newborns with visible neurological disorders (e.g. with symptoms of hypertonia, impaired reflex reactions in the orofacial area) and\u002For significant abnormalities in central nervous system (CNS) imaging studies (e.g. III-IV degree intraventricular hemorrhages, CNS defects, hydrocephalus);\n* newborns of mothers with anhydramnios;\n* lack of consent to conduct at least two bottle-feeding sessions;\n* a child fed with a different type of teat than the one used in the study.","ALL","28 Weeks","32 Weeks",{"count":20,"type":21},30,"ESTIMATED","4 Months","OBSERVATIONAL","The aim of this study is to assess masseter muscle thickness using ultrasounds during oral feeding process in premature infants with gestational age from 28+0\u002F7 to 32+0\u002F7 weeks, taking into account the qualitative and quantitative aspects of oral feeding. The main question it aims to answer is: Does the thickness of the masseter muscle influence the course of development of the feeding function in premature newborns? The study will assess the influence of masseter muscle thickness on the oral feeding process in premature infants, which has significant cognitive value due to the dynamic development of feeding function in this group of newborns. Transitioning from enteral feeding via a nasogastric tube to full oral feeding is a crucial stage in the development of one of the most fundamental life functions - nutrition. Complete, effective, and safe oral feeding is also a factor in determining a newborn's discharge from the hospital. Research in the area of feeding is an important and ongoing goal for improving neonatal care in neonatal units. Furthermore, this study will provide preliminary data on masseter muscle thickness in premature infants, which may serve as a basis for further research.",[26],"Premature Infants",[28,29,30,31],"premature infant","masseter muscle","ultrasonography","oral feeding","NOT_YET_RECRUITING","2026-06-14",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2029-12",{"name":42,"class":43},"Polish Mother Memorial Hospital Research Institute","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100255235","nirs-monitoring-in-premature-infants-100255235","NCT02601339","NIRS Monitoring in Premature Infants","Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus","1. GM-IVH group:\n\n   Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI).\n\n   Exclusion criteria for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection.\n2. PHH group:\n\n   Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI.\n\n   Exclusion criteria for PHH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI.\n3. HC group:\n\n   Inclusion criteria for HC group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar \\>7 at 5 min.\n\n   Exclusion criteria for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection.\n4. VC group:\n\nInclusion criteria for VC group: \\\u003C 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH.\n\nExclusion criteria for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI.",true,"0 Months","12 Months",{"count":55,"type":21},70,"This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and\u002For post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment.\n\nThis is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.",[58,26,59,60],"Hemorrhage","Newborn","Hydrocephalus",[62],"spectroscopy, Near-Infrared","RECRUITING","2026-03-16",{"date":66,"type":36},"2026-03-18",{"date":68,"type":36},"2015-04",{"date":70,"type":21},"2026-12",{"name":72,"class":43},"Boston Children's Hospital",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100621243","phase-1-pneumostem-for-improving-respiratory-outcomes-in-very-premature-infants-diagnosed-with-early-pulmonary-arterial-hypertension-100621243","NCT07368088","PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension","A Clinical Study of Advanced Regenerative Medicine to Evaluate the Safety and Potential Efficacy of PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension","REVIVE-PH","Inclusion Criteria:\n\n1. Premature infants within 2 weeks of birth with a gestational age of 28 weeks or less or birth weight of less than 1,250g who require continuous invasive mechanical ventilation\n2. When diagnosed with early pulmonary arterial hypertension satisfying condition ① or ② up to 14 days after birth:\n\n   * When on or more of the following abnormal findings are present on echocardiography performed between 4 and 14 days after birth (findings at 1-3 days after birth correspond to early neonatal transition):\n\n     1. Sytemic or suprasystemic pulmonary artery pressure \\>40mmHg(based on peak Doppler velocity of tricuspid regurgitation)\n     2. Right-to-left or bidirectional shunt through patent ductus arteriosus, foramen ovale, or atrial septal defect\n     3. Flattened interventricular septum or D-shaped left ventricle at end systole ② When receiving nitric oxide(NO) inhalation therapy for persistent pulmonary hypertension of the newborn(PPHN) within 3 days after birth\n\nExclusion Criteria:\n\n1. Those witth cyanotic congenital heart defects or acyanotic congenital heart defects causing heart failure, excluding patent ductus arteriosus in premature infatns\n2. Those with severe pulmonary malformations such as congenital diaphragmatic hernia or congenital cystic lung disease\n3. Those who underwent surgery within 72 hours before or after administration of the investigational cell product, or those for whom surgery is anticipated\n4. Those who received surfactant within 24 hours prior to administration of the investigattional cell product\n5. Those with chromosomal abnormalities accompanied by severe malformations(such as Edwards syndrome, Patau syndrome, Down syndrome, etc.) and severe congenital malformations(such as hydrocephalus, encephalocele, etc.)\n6. Those with severe congenital infectious diseases(such as herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)\n7. Those with severe sepsis or shock due to active infection not adequately treated with antibiotics\n8. Those who have a history of participation in other advanced regenerative medicine clinical studies or clinical trials\n9. Others deemed inappropriate by tthe investigator to participate in this advanced regenerative medicine clinical study","1 Day","14 Days",{"count":85,"type":21},12,"INTERVENTIONAL",[88],"PHASE1","The goal of this clinical trial is to evaluate the safety and potential efficacy of PNEUMOSTEM® for improving respiratory outcomes in very premature infants diagnosed with Early Pulmonary Arterial Hypertension. The main questions it aims to answer are:\n\n* In very premature infants diagnosed with early pulmonary arterial hypertension, will a single intratracheal administration of PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells) result in improvement of pulmonary arterial hypertension based on echocardiographic assessment?\n* In very premature infants diagnosed with early pulmonary arterial hypertension who show improvement of pulmonary arterial hypertension based on echocardiographic assessment following a single intratracheal administration of PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells), at what time point does this improvement occur?\n\nParticipants will:\n\n* Single intratracheal dose of PNEUMOSTEM® at 2.0 x 10,000,000 cells\u002Fkg\n* Acute adverse event monitoring: 24 hours post-administration for safety assessment\n* Follow- up time points: Day 1(Baseline, PNEUMOSTEM® administration), Day 2, Week 1, Week 2, Postnatal Day 28, PMA 36\\~40 weeks",[91,26],"Pulmonary Arterial Hypertension (PAH)","2026-01-20",{"date":94,"type":36},"2026-01-26",{"date":96,"type":21},"2026-03",{"date":98,"type":21},"2027-07",{"name":100,"class":43},"Samsung Medical Center",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":86,"phases":112,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":101},"100620912","therapeutic-touch-in-premature-infants-100620912","NCT07363785","Therapeutic Touch in Premature Infants","The Effects Of Therapeutic Touch Applied To Premature Infants On Behavioural Responses, Comfort And Physiological Parameters: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Infants with a gestational age between 28-37 weeks,\n* Birth weight of 1500 gr and above,\n* Post-feeding,\n* Hospitalized in Level 1 or Level 2 NICU,\n* Stable health status will be included in the study.\n\nExclusion Criteria:\n\n* Infants with:heart disease,\n* congenital anomalies,\n* skin health problems,\n* neurological diseases,\n* mechanical ventilation,\n* those receiving continuous opioid, sedative, anticonvulsant or corticosteroid treatment,\n* active infection or antibiotic treatment,\n* undergoing surgery will be excluded from the study.","37 Weeks",{"count":111,"type":21},62,[113],"NA","Preterm birth is associated with increased physiological instability, stress responses, and developmental vulnerability due to immature organ systems and prolonged exposure to invasive procedures and environmental stressors in neonatal intensive care units (NICUs). In recent years, non-pharmacological, touch-based interventions have gained attention for their potential to support neurodevelopment, improve comfort, and stabilize physiological parameters in preterm infants.\n\nTherapeutic Touch (TT) is a non-invasive, holistic intervention based on the modulation of the human energy field through gentle hand movements, aiming to reduce stress, promote relaxation, and support physiological regulation. Although TT has demonstrated beneficial effects in various populations, evidence regarding its effects on preterm infants remains limited.\n\nThis randomized controlled study aims to evaluate the effects of Therapeutic Touch on behavioral responses, comfort levels, and physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) in preterm infants hospitalized in the NICU. The findings are expected to contribute evidence for safe, supportive, and holistic neonatal care practices.",[26],[117,118,119,120,121],"Preterm Infant","Therapeutic Touch","Behavioral Responses","Neonatal Comfort","Physiological Parameters","2026-01-14",{"date":124,"type":36},"2026-01-23",{"date":126,"type":21},"2026-01-30",{"date":128,"type":21},"2026-05-30",{"name":130,"class":43},"Selcuk University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":86,"phases":142,"briefSummary":143,"conditions":144,"keywords":150,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":101},"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":141,"type":21},40,[113],"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.",[26,145,146,147,148,149],"Sleep Quality","İnfant Stress","İnfant Comfort","Vital Signs","NICU",[151,152,149,153,154,155,156],"Preterm infants","neonatal massage","sleep quality","stress reduction","comfort","vital signs","2025-12-22",{"date":159,"type":36},"2026-01-07",{"date":161,"type":36},"2025-08-15",{"date":163,"type":21},"2026-06-15",{"name":165,"class":43},"Yuzuncu Yil University",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":86,"phases":177,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":196},"100612470","phase-2-anakinra-pilot-2---a-study-to-optimise-dose-and-route-of-administration-of-anakinra-in-preterm-infants-100612470","NCT07254000","Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants","AP2","Inclusion Criteria:\n\n* Born between 24+0 and 28+6 weeks of gestation\n\nExclusion Criteria:\n\n* Inability of the legal representatives to consent,\n* Genetic syndromes,\n* Severe cardiac anomalies,\n* Substantial pre-\u002Fperinatal compromise,\n* Congenital diaphragmatic hernia,\n* Intrauterine stroke,\n* Conditions that could confound trial results\n* Imminent death or plan for comfort \u002F palliative care\n* Infants born outside the recruiting institutions","24 Weeks","29 Weeks",{"count":176,"type":21},24,[178],"PHASE2","A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.",[26,181,182],"Very Premature Infants","Inflammation",[184,185,186,187],"anakinra","bronchopulmonary dysplasia","diffuse white matter injury","very premature infants","2025-11-19",{"date":190,"type":36},"2025-11-28",{"date":192,"type":36},"2025-06-27",{"date":70,"type":21},{"name":195,"class":43},"Monash Medical Centre",2,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":86,"phases":209,"briefSummary":210,"conditions":211,"keywords":215,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":101},"100504495","optimization-of-saturation-targets-and-resuscitation-trial-optistart-100504495","NCT05849077","Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)","Optimization of Saturation Targets And Resuscitation (OptiSTART): Multicenter Randomized Controlled Trial","OptiSTART","Inclusion Criteria:\n\n-Neonates with OB gestational age 22-30 weeks\n\nExclusion Criteria:\n\n* Prenatally diagnosed cyanotic congenital heart disease\n* Prenatally diagnosed congenital diaphragmatic hernia\n* Parents request no resuscitation\n* If preductal saturations can not be measured by 3 minutes after pulse oximeter sensor is applied to the newborn","0 Minutes","10 Minutes",{"count":208,"type":21},700,[113],"This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term morbidities? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (≤ 30%) inspired O2 concentration (FiO2) and subsequent titration to achieve a specified target SpO2 range. These SpO2 targets are based on approximated 50th percentile SpO2 (Sat50) observed in healthy term infants. However, the optimal SpO2 targets remain undefined in the preterm infants. Recent data suggest that the current SpO2 targets (Sat50) may be too low. The investigators plan to conduct a multicenter RCT of Sat75 versus Sat50 powered for survival without BPD. The investigators will randomize 700 infants, 23 0\u002F7- 30 6\u002F7 weeks' GA, to 75th percentile SpO2 goals (Sat75, Intervention) or 50th percentile SpO2 goals (Sat50, control). Except for the SpO2 targets, all resuscitations will follow NRP guidelines including an initial FiO2 of 0.3. In Aim 1, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without lung disease (BPD). In addition, the investigators will compare the rates of other major morbidities such as IVH. In Aim 2, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without neurodevelopmental impairment at 2 years of age. In Aim 3, the investigators will determine whether targeting Sat75 compared to Sat50 decreases oxidative stress.",[26,212,213,214],"Bronchopulmonary Dysplasia","Intraventricular Hemorrhage","Neurodevelopmental Outcomes",[216,217],"neonatal resuscitation","oxygen","2025-07-30",{"date":220,"type":36},"2025-08-05",{"date":222,"type":36},"2024-02-26",{"date":224,"type":21},"2029-04-01",{"name":226,"class":43},"University of Texas Southwestern Medical Center",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":51,"sex":16,"minAge":4,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":101},"100541642","infant-crying-a-bioacoustic-prognostic-signal-for-neurodevelopment-100541642","NCT06332521","Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment","BABYCRY_1000","Inclusion Criteria:\n\n* For a full-term baby \\> 37 weeks\n* For a premature baby \\\u003C 37 weeks\n* Born in the maternity ward of the Saint-Etienne University Hospital\n* Holder of parental authority having received informed information about the study and their right to object\n* Holder of parental authority affiliated to or beneficiary of a social security system\n* Eutrophic between the 10th and 90th percentile on the neonatal curves)\n\nExclusion Criteria:\n\n* Refusal of participation by the holder of parental authority\n* Antenatal pathology, nor perinatal asphyxia\n* Holder of minor parental authority\n* Holder of parental authority under curatorship or guardianship\n* Abnormal T1 audiological screening test.","4 Days",{"count":236,"type":21},1100,"Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.\n\nCrying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry.",[239,26,240],"Newborn; Vitality","Infant Development",[59,242],"Crying","2025-05-22",{"date":245,"type":36},"2025-05-28",{"date":247,"type":36},"2024-03-20",{"date":249,"type":21},"2028-03-01",{"name":251,"class":43},"Centre Hospitalier Universitaire de Saint Etienne",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":51,"sex":16,"minAge":259,"maxAge":18,"enrollmentInfo":260,"targetDuration":4,"studyType":86,"phases":262,"briefSummary":263,"conditions":264,"keywords":269,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":101},"100558760","pilot-trial-investigating-every-other-day-dosing-of-oral-iron-in-premature-infants-iqonic-100558760","NCT06555315","Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)","Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.","Inclusion Criteria:\n\n* Children (Minor \\\u003C 18 years of age)\n* Neonates\n* Hospitalized\n* Premature infants who are on full enteral feeds and are started on oral iron\n* Premature infants who completed 26 0\u002F7 to 32 6\u002F7 weeks' gestation at birth\n\nExclusion Criteria:\n\n• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization","26 Weeks",{"count":261,"type":21},100,[113],"Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates",[265,26,266,267,268],"Very Low Birth Weight Infant","Anemia of Prematurity","Iron Deficiency, Anaemia in Children","Extremely Low Birth Weight",[270,271,272,273],"Premature infants","Iron","anemia of prematurity","iron deficiency","2024-08-13",{"date":276,"type":36},"2024-08-15",{"date":278,"type":36},"2024-08-01",{"date":280,"type":21},"2026-03-28",{"name":282,"class":43},"CHRISTUS Health"]