[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prematurity":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,43,77,109,140,171,200,228,255,283,310,333,354,374,400,430,458,486,512,537,568,595,624,655,679],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100548402","milk-and-growth-in-children-magic-born-very-preterm-a-randomized-trial-100548402",false,"NCT06420531","Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial","A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm","MAGIC","Inclusion Criteria:\n\n* Gestational age between 27 0\u002F7 and 31 6\u002F7 weeks\n* Birthweight of 1500 grams or less\n* Human milk feeding during the first 14 days after birth\n* Full enteral feeding (120mL\u002Fkg\u002Fday or more) within the first 14 days after birth\n\nExclusion Criteria:\n\n* Necrotizing enterocolitis stage 2 or greater\n* Spontaneous intestinal perforation\n* Major congenital\u002Fchromosomal anomalies\n* Terminal illness requiring limited or withheld support\n* Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)\n* Any formula feeding within the first 14 days after birth","ALL","6 Hours","4 Days",{"count":22,"type":23},486,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL\u002Fkg\u002Fday on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.",[29],"Prematurity","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":34},"2025-09-16",{"date":38,"type":23},"2030-08-30",{"name":40,"class":41},"University of Alabama at Birmingham","OTHER",4,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":52,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100639413","antenatal-vs-postnatal-transport-team-positioning-in-extremely-preterm-outborn-infants-100639413","NCT07580859","Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants","A Prospective French National Study of the Impact of Antenatal Versus Postnatal Positioning of a Neonatal Transport Team on Survival and Severe Neurodevelopmental Delay at Two Years in Outborn 23-28 Weeks Infants : outbornTRANSFER Study Protocol","OutbornTRANSF","Eligible for inclusion are infants for whom an antenatal call to the emergency medical service (SAMU) was initiated due to prematurity (imminent delivery and infant alive at the time of the call) and who:\n\n* Were born outside a level 3 maternity hospital (outborn birth) in mainland France\n* Have a gestational age at birth between of 23+0 - 28+6\n* Have parents who speak and understand French (required for telephone follow-up) To assess parent-related outcomes, parents will also be included in the study if their infant is eligible and if they have not objected to participation.\n\nInfants will not be included if one or both parents are unable to speak and understand French, if at least one of the parents is opposed to inclusion, if they had lethal congenital malformations or if they were born outside hospital (accidental premature home births).","0 Days","28 Months",{"count":54,"type":23},627,"OBSERVATIONAL","The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care).\n\nThis project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age.\n\nStudy will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care.\n\nIf parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents.\n\nThrough a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.",[58,59,29],"Prematurity Complications","Neurodevelopment Outcome",[29,61,62,63,64,65],"Outborn","Transport","Mortality","Cohort study","Neurodevelopment","NOT_YET_RECRUITING","2026-05-26",{"date":69,"type":34},"2026-05-28",{"date":71,"type":23},"2026-06",{"date":73,"type":23},"2030-09",{"name":75,"class":41},"Assistance Publique - Hôpitaux de Paris",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":76},"100465418","phase-2-darbe-plus-iv-iron-to-decrease-transfusions-while-maintaining-iron-sufficiency-in-preterm-infants-100465418","NCT05340465","Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants","Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants","DIVI","Inclusion Criteria:\n\n• NICU patients (male and female) born at 24-0\u002F7 to 31-6\u002F7 weeks of gestation\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Known fetal\u002Finfant anomalies of clinical significance (brain, cardiac, chromosomal anomalies)\n* Parental consent unable to be obtained by 72 hours after birth\n* Central hematocrit \\> 65%\n* Evidence of high iron stores prior to enrollment (e.g. Ferritin \\>400 ng\u002FmL with corresponding ZnPP\u002FH of \\\u003C30, Transferrin saturation \\>75%, iron \\> 200 mcg\u002FdL, TIBC \\\u003C 100 mcg\u002FdL)\n* Culture proven sepsis, meningitis, urinary tract infection, or other significant infection at the time of enrollment\n* Mother under 18 years of age\n* Unable to consent in English or Spanish","3 Days",{"count":87,"type":23},120,[89],"PHASE2","In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants.\n\nInvestigators hypothesize that in infants \\\u003C 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome",[29,92,93,94],"Iron-deficiency","Iron Deficiency Anemia","Iron Malabsorption",[96,97,98,99,100],"prematurity","iron deficiency","anemia","darbepoetin","IV Iron","2026-05-21",{"date":67,"type":34},{"date":104,"type":34},"2022-11-27",{"date":106,"type":23},"2027-06-30",{"name":108,"class":41},"University of Washington",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":24,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100590293","nourishing-tomorrow-role-of-medically-tailored-groceries-in-addressing-food-insecurity-during-pregnancy-100590293","NCT06965530","Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy","The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships","Inclusion Criteria:\n\n* 18 years of age and older\n* Pregnant patients \\>10 weeks and \\\u003C22 weeks gestation at randomization (must be consented by 18 weeks)\n* Eligible for Medicaid\n* Singleton pregnancy, confirmed by ultrasound\n* An established patient of the UH or Metro pregnancy clinic\n* English speaking\n* Lives in Cuyahoga County, Ohio\n\nExclusion Criteria:\n\n* Under 18 years old",true,"FEMALE","18 Years","55 Years",{"count":121,"type":23},360,[26],"Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.",[125,29,126],"Pregnancy Related","Birth Outcome, Adverse",[128,129],"Randomized trial","Behavioral intervention","2026-04-16",{"date":132,"type":34},"2026-04-20",{"date":134,"type":34},"2025-11-12",{"date":136,"type":23},"2029-05-31",{"name":138,"class":41},"Case Western Reserve University",2,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":24,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":167,"leadSponsor":169,"locationsCount":76},"100633032","non-invasive-ventilation-interfaces-and-nasal-pressure-injury-in-preterm-infants-100633032","NCT07521410","Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants","Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants","NIV-MDRPI","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks\n* Receiving non-invasive ventilation support in a neonatal intensive care unit\n* Receiving non-invasive ventilation for at least 4 days\n* Parental consent obtained\n\nExclusion Criteria:\n\n* Infants requiring intubation\n* Presence of congenital anomalies\n* Pre-existing nasal injury or trauma\n* Presence of skin disease\n* Nasal lesions due to previous nasotracheal intubation\n* Upper airway malformations\n* Infants transferred from another center after receiving more than 24 hours of non-invasive ventilation","0 Minutes","28 Days",{"count":151,"type":23},75,[26],"The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit.\n\nThe main questions it aims to answer are:\n\n* Do different non-invasive ventilation interfaces affect how often nasal pressure injury develops?\n* Do these interfaces affect the severity of nasal pressure injury and the condition of the nasal skin?\n\nResearchers will compare three types of non-invasive ventilation interfaces (binasal prong, nasal cannula, and nasal mask) to see if one method is more effective in reducing nasal pressure injury.\n\nParticipants will:\n\n* Be randomly assigned to one of three groups (binasal prong, nasal cannula, or nasal mask)\n* Receive non-invasive ventilation support using the assigned interface for at least 4 days\n* Have their nasal skin assessed every 12 hours for 96 hours using standardized scales\n* Continue to receive routine care in the neonatal intensive care unit",[155,29],"Medical Device-Related Pressure Injury",[157,158,159,160,161,162,163],"Preterm infants","Non-invasive ventilation","Nasal pressure injury","Medical device-related pressure injury","Neonatal intensive care unit","CPAP","Nasal interface","2026-04-13",{"date":130,"type":34},{"date":132,"type":23},{"date":168,"type":23},"2026-10-24",{"name":170,"class":41},"Istanbul University - Cerrahpasa",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":24,"phases":182,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":139},"100557298","the-impact-of-music-medicine-on-preterm-brain-development-and-behavior-100557298","NCT06536296","The Impact of Music Medicine on Preterm Brain Development and Behavior","The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Trial \"The Lullaby Study\"","Inclusion Criteria:\n\n* Very preterm infants born between 24+0 and 30+6 weeks' gestational age (GA) from 2 level III NICUs (Brigham and Women's Hospital, Boston, MA and Yale New Haven, CT)\n* Infants who are medically stable per the clinical care team\n\nExclusion Criteria:\n\n* Infants with major genetic or congenital anomalies known to be associated with developmental delay\n* Infants with severe brain injury (such as intraparenchymal hemorrhage, severe white matter injury)\n* Infants who are severely ill infants for whom MBI is not feasible\n* Infants of parents who cannot complete questionnaires in English or Spanish.","24 Weeks","30 Weeks",{"count":181,"type":23},243,[26],"The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.",[185,186,29,187],"Infant Development","Language Development","Stress",[189,65,190],"Preterm","Music-based Intervention","2026-03-23",{"date":193,"type":34},"2026-03-25",{"date":195,"type":34},"2025-05-19",{"date":197,"type":23},"2031-03-01",{"name":199,"class":41},"Brigham and Women's Hospital",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":116,"sex":18,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":24,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":76},"100628960","effects-of-a-parenting-skills-training-program-on-maternal-self-efficacy-perceived-social-support-and-infant-development-in-mothers-of-preterm-infants-aged-6-12-months-100628960","NCT07468435","Effects of a Parenting Skills Training Program on Maternal Self-Efficacy, Perceived Social Support, and Infant Development in Mothers of Preterm Infants Aged 6-12 Months","Investigation of the Effects of a Parenting Skills Training Intervention Applied to Mothers of Preterm Infants Aged 6-12 Months on Maternal Parenting Self-Efficacy, Perceived Social Support, and Infant Developmental Level","Inclusion Criteria:\n\n* For Mothers Being able to read and write in Turkish Providing written informed consent Having a preterm infant with a corrected age between 6 and 12 months Not having a diagnosed psychiatric disorder\n* For Infants Being born preterm between week of 32 and 37 Not presenting any neurological or other conditions Having a corrected age between 6 and 12 months\n\nExclusion Criteria:\n\n* For Mothers Having any neurological, musculoskeletal and psychiatric diagnosis to effect the caregiving role\n* For Infants Use of multiple daily medications Hospitalization in the neonatal intensive care unit (NICU) for longer than 2 months","6 Months","12 Months",{"count":210,"type":23},26,[26],"The goal of this clinical trial is to evaluate whether a structured parenting skills training intervention can improve maternal parenting self-efficacy, perceived social support, and infant developmental outcomes in mothers of preterm infants aged 6-12 months (corrected age).\n\nThe main questions it aims to answer are:\n\nDoes a parenting skills training intervention improve maternal parenting self-efficacy?\n\nDoes the intervention increase mothers' perceived social support and positively influence infant developmental levels?\n\nResearchers will compare mothers who receive the parenting skills training intervention with a control group receiving standard care to determine whether the intervention leads to greater improvements in maternal and infant outcomes.\n\nParticipants will:\n\nComplete baseline, post-intervention, and follow-up assessments of parenting self-efficacy and perceived social support\n\nHave their infants assessed using standardized developmental evaluation tools\n\nParticipate in a structured, home-based parenting skills training program consisting of multiple sessions (intervention group only)\n\nTake part in semi-structured interviews before and after the intervention to share their experiences and perceived needs",[29],[215,216,217,218],"parental self-efficacy","social support","preterm infants","parenting skills","2026-03-09",{"date":221,"type":34},"2026-03-12",{"date":223,"type":23},"2026-03-13",{"date":225,"type":23},"2026-08-30",{"name":227,"class":41},"Medipol University",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":236,"maxAge":207,"enrollmentInfo":237,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":76},"100605944","study-of-the-interprofessional-reproducibility-of-a-clinical-observation-scale-for-the-development-of-very-premature-infants-100605944","NCT07169110","Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants","Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants Aged 1 to 6 Months Corrected, for the Very Early Detection of Developmental Disorders.","SPIN-NA","Inclusion Criteria:\n\n* Male or female child born between 27 and 32 weeks of amenorrhea in a singleton pregnancy;\n* Child hospitalized in the neonatology unit of Toulouse University Hospital;\n* Family home within a 15 km radius of Toulouse to allow for home visits for filming;\n* Parents with parental authority affiliated with a social security scheme or equivalent;\n* Signature of the informed consent form by the parents with parental authority\n* Absence of serious illness, as defined in the exclusion criteria;\n* The child may participate in another study during the duration of this study, without an exclusion period.\n\nExclusion Criteria:\n\n* Child with a severe organic pathology detected during hospitalization and requiring specific and appropriate care for the diagnosed pathology;\n* Child with a neurological complication: Grade 3 or 4 intraventricular hemorrhage, periventricular cavitary leukomalacia, excluding frontal leukomalacia;\n* Child with a malformation or multiple malformations that impair the neurological prognosis;\n* Child with genetic or metabolic diseases;\n* Fetal alcohol syndrome;\n* Parental authority holders under guardianship, curatorship, or legal protection;\n* Any family condition that prevents compliance with the procedures set out in the study protocol, in the opinion of the investigator.\n* Family members who do not speak French fluently, in order to ensure understanding of the system and the proposed care.","1 Month",{"count":238,"type":23},35,"The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age. No tool is available to characterize the mechanisms of early developmental processes and their deviations. We propose an analytical observation grid of developmental mechanisms in the first few months, in order to identify warning signs of developmental deviations and help define the nature and type of early care for vulnerable infants.",[29],[242,243,244,245],"Premature infant","early development","early care intervention","early evaluation","2025-12-11",{"date":248,"type":34},"2025-12-18",{"date":250,"type":23},"2025-12-22",{"date":252,"type":23},"2026-12-30",{"name":254,"class":41},"University Hospital, Toulouse",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":117,"minAge":118,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":24,"phases":265,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":76},"100607046","phase-4-azithromycin-and-ampicillin-for-late-pprom-100607046","NCT07183462","Azithromycin and Ampicillin for Late PPROM","ALPRO","Inclusion Criteria:\n\n* Maternal age 18-50\n* Premature rupture of membranes\n* Gestational age 34.0 and 36.4 weeks\n* Singleton pregnancy\n\nExclusion Criteria:\n\n* Multiple gestations\n* Individuals in active labor (defined as 3 cm dilatation and 80% effacement or more. or regular uterine construction of more than 4 in 10 minutes)\n* Meconium stain amniotic fluid\n* Non-reassuring fetal heart rate or status\n* Maternal or fetal indication for labor:\n\n  * Suspected Chorioamnionitis\n  * Suspected placental abruption\n  * Any maternal morbidity requiring labor\n* Cervical cerclage in place.\n* Major fetal malformation or known chromosomal abnormalities.\n* Stillbirth.\n* Sensitivity to Macrolides Antibiotics","50 Years",{"count":264,"type":23},311,[266],"PHASE4","The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy.\n\nThe main question it aims to answer is:\n\nDoes the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone?\n\nResearchers will compare two antibiotic regimens:\n\nAmpicillin alone, which is the current standard care Ampicillin with azithromycin, a broader regimen that may better prevent infections and prolong pregnancy\n\nParticipants will:\n\nReceive one of the two antibiotic treatments during hospitalization. Be monitored until delivery for signs of infection and labor\n\nAll participants will stay in the hospital until delivery. The study also looks at how the antibiotic choice may affect the time between membrane rupture and delivery, maternal infections, and the need for neonatal intensive care.",[269,270,271,272,273,29],"Pregnancy Complications, Infectious","Premature Birth","Neonatal Diseases and Abnormalities","Antibiotic Prophylaxis","Latency Period","2025-12-10",{"date":248,"type":34},{"date":277,"type":34},"2025-09-10",{"date":279,"type":23},"2029-07-31",{"name":281,"class":282},"Sheba Medical Center","OTHER_GOV",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":24,"phases":291,"briefSummary":292,"conditions":293,"keywords":296,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":76},"100563956","influence-of-flow-rate-change-on-co2-levels-during-high-flow-nasal-ventilation-hfnv-in-preterm-infants-100563956","NCT06622902","Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.","Inclusion criteria:\n\n* Gestational age 240 to 336.\n* At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).\n* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.\n* At least 6 hours from surfactant administration.\n* Parental consent\n\nExclusion criteria:\n\n* If flow is \\<3 and tcCO2 related pCO2 is\\<40mmHg.\n* If Flow is ≥5 bpm and tcCO2 related pCO2 is\\>60mmHg.\n* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.",{"count":290,"type":23},45,[26],"Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding.\n\nAim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants.\n\nMethods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours.\n\nOutcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics.\n\nStatistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.",[294,29,295],"Respiratory Distress Syndrome","Non Invasive Ventilation",[297,96,298,299,300],"Respiratory distress syndrome","HIGH FLOW","CO2","VENTILATION","2025-11-26",{"date":303,"type":34},"2025-11-28",{"date":305,"type":34},"2023-08-16",{"date":307,"type":23},"2026-12-31",{"name":309,"class":41},"Rambam Health Care Campus",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":116,"sex":18,"minAge":4,"maxAge":317,"enrollmentInfo":318,"targetDuration":320,"studyType":55,"phases":4,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100603833","this-study-aims-to-evaluate-the-validity-of-family-led-recordings-for-general-movement-assessment-gma-compared-to-provider-led-recording-in-neonates-born-under-29weeks-100603833","NCT07141654","This Study Aims to Evaluate the Validity of Family-led Recordings for General Movement Assessment (GMA) Compared to Provider-led Recording in Neonates Born Under 29weeks","Empowering Families in Early Detection: Implementing Family-Led Recording for Early Diagnosis of Cerebral Palsy in Preterm Infants","Inclusion Criteria:\n\n1. Newborns \\\u003C 29 weeks gestation admitted to the Montréal Children's hospital (MCH) Neonatal Intensive Care Unit (NICU), who are anticipated to be followed at the MCH Neonatal Follow-up Clinic\n2. Parents can communicate in French or English\n3. Intention to come for regular follow-up in the MCH Neonatal Clinic and\u002For Physical\u002FOccupational therapy appointments\n\nExclusion Criteria:\n\n* None","29 Weeks",{"count":319,"type":23},100,"18 Months","This study aims to evaluate the validity of family-led recordings for General Movements Assessment (GMA) compared to provider-led recordings in neonates born \\\u003C29 weeks.",[323,324,29],"Cerebral Palsy","General Movement Assessment","2025-10-01",{"date":327,"type":34},"2025-10-07",{"date":325,"type":23},{"date":330,"type":23},"2028-02",{"name":332,"class":41},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":118,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":76},"100425433","study-of-the-involvement-of-fatty-acids-in-retinopathy-of-prematurity-relationship-between-retinopathy-of-prematurity-and-the-rate-of-expression-of-transplacental-fatty-acid-receptors-100425433","NCT04819893","Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.","OMEGAROP 2","Inclusion Criteria:\n\n1. Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.\n2. Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.\n3. ≥18 years\n4. Mothers not under legal protection\n\nExclusion Criteria:\n\n1. Mothers giving birth between 29WA and 38WA+6 days\n2. Mothers in critical condition.\n3. Person not affiliated to national health insurance\n4. For full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).",{"count":341,"type":23},135,"The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.",[29,344],"Retinopathy","2025-09-17",{"date":347,"type":34},"2025-09-22",{"date":349,"type":34},"2021-04-20",{"date":351,"type":23},"2027-02",{"name":353,"class":41},"Centre Hospitalier Universitaire Dijon",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":18,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":76},"100480551","maternal-stress-milk-composition-and-preterm-neurodevelopment-100480551","NCT05537454","Maternal Stress, Milk Composition, and Preterm Neurodevelopment","Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes","Inclusion Criteria:\n\n* preterm infant born between 28 0\u002F7 and 34 6\u002F7 weeks' gestation that are medically stable for study procedures\n* mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery\n\nExclusion Criteria:\n\n* infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).\n* mothers: a) alcohol consumption \\>1 drink per week or any tobacco consumption during pregnancy, b) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding\u002Fgrowth","28 Weeks","34 Weeks",{"count":87,"type":23},"This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.",[29],"2025-09-09",{"date":277,"type":34},{"date":369,"type":34},"2022-12-09",{"date":371,"type":23},"2030-07-31",{"name":373,"class":41},"University of Minnesota",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":382,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":24,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":76},"100394279","exclusive-human-milk-in-preterm-neonates-and-early-vascular-aging-risk-factors-neovasc-100394279","NCT04413994","Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)","Effects of an Exclusive Human-milk Diet in Preterm NEOnates on Early VASCular Aging Risk Factors (NEOVASC)","NEOVASC","Preterm-born group:\n\nInclusion Criteria:\n\n1. Extremely preterm infants with a birth weight of 500-1250g.\n2. Feeding is NPO or exclusive human milk prior to enrollment.\n3. Parent(s) willing to sign informed consent.-\n\nExclusion Criteria:\n\n1. Infants with a birth weight \\\u003C500g or \\>1250g\n2. Subjects diagnosed with inborn errors of metabolism such as galactosemia, phenylketonuria\n3. Subjects who have not been NPO or fed exclusive human milk diet prior to enrollment.\n4. Presence of major congenital malformation.\n5. Presence of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to enrollment.\n6. Parent(s) not willing to sign informed consent.\n7. Unable to participate for any reason based on the decision of the study investigator (e.g. unlikely to survive the study period).\n\nTerm-born group:\n\nInclusion criteria\n\n1. Term-born children with an adequate birth weight\n2. Parent(s) willing to sign informed consent\n\nExclusion criteria\n\n1. Subjects with acute or chronic illness\n2. Parent(s) not willing to sign informed consent","1 Day","5 Years",{"count":385,"type":23},200,[26],"Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.",[29,389],"Vascular Aging","2025-08-22",{"date":392,"type":34},"2025-08-29",{"date":394,"type":34},"2020-10-09",{"date":396,"type":23},"2028-06-01",{"name":398,"class":399},"Prolacta Bioscience","INDUSTRY",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":382,"maxAge":85,"enrollmentInfo":408,"targetDuration":4,"studyType":24,"phases":410,"briefSummary":412,"conditions":413,"keywords":416,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":139},"100518101","phase-2-caffeine-as-an-adjuvant-therapy-for-late-preterm-infants-with-respiratory-distress-100518101","NCT06026163","Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress","Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial","CAT\u002FLPT","Inclusion Criteria:\n\n* Newborn infants at gestational age 34 0\u002F7 through 36 6\u002F7\n* Presented with respiratory distress\n* Require respiratory support in the form of any of the following :\n\nA) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.\n\nExclusion Criteria:\n\n1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.\n\n3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.\n\n5- Late preterm with history of maternal substance abuse",{"count":409,"type":23},134,[89,411],"PHASE3","Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg\u002Fkg and maintenance dose of 10 and 20 mg\u002Fkg\u002Fday reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.\n\nThe investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.\n\nThe investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.",[29,414,415],"Respiratory Disease","Ventilator Lung; Newborn",[417,418,419,420],"caffeine","preterm","newborn","respiratory support","2025-06-24",{"date":423,"type":34},"2025-06-27",{"date":425,"type":34},"2023-10-12",{"date":427,"type":23},"2028-01-01",{"name":429,"class":282},"Ministry of Health, Saudi Arabia",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":116,"sex":18,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":24,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":76},"100515279","different-intervention-models-of-premature-infants-based-on-the-icf-biopsychosocial-model-100515279","NCT05989438","Different Intervention Models of Premature Infants Based on the ICF Biopsychosocial Model","Analysis of the Impact of Different Intervention Models on the Neuropsychomotor Development of Premature Infants Based on the ICF Biopsychosocial Model","Inclusion Criteria:\n\n* 1\\. Gestational age less than 37 weeks, corrected age between 4 and 12 months (one and a half month window) and at 24 months (four months window)\n* Babies from the High Risk Outpatient Clinic of the UCS Clinical Center, registered there;\n* Authorization of those responsible for the minor consenting to participation in the study by signing the Free and Informed Consent Form (TCLE).\n\nExclusion Criteria:\n\n* All those subjects who do not follow the items mentioned above;\n* Presenting neurological diseases;\n* Presence of acute diseases (eg pneumonia, bronchiolitis, trauma)\n* Musculoskeletal alterations;\n* Genetic syndromes;\n* In genetic investigation;\n* Heart diseases with indication for surgical intervention;\n* Untreated congenital torticollis;\n* Congenital clubfoot;\n* Cerebral hemorrhage grade IV\n* Those who do not undergo the first and\u002For last evaluation;\n* Incomplete evaluation;\n* Convulsive crisis during study period;\n* Participants from other intervention programs.","4 Months","2 Years",{"count":440,"type":23},60,[26],"Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model.",[29],[29,445,446,447,448],"Physiotherapy","CIF","Child development","Early Intervention","2025-06-19",{"date":451,"type":34},"2025-06-25",{"date":453,"type":34},"2023-08-01",{"date":455,"type":23},"2026-01-11",{"name":457,"class":41},"Federal University of Health Science of Porto Alegre",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":117,"minAge":118,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":24,"phases":468,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":76},"100590256","vaginal-probiotics-during-pregnancy-after-premature-24-32-weeks-of-gestation-preterm-rupture-of-membranes-100590256","NCT06965049","Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes","Multicentric Clinical Pilot Trial Testing the Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 24 and 32 Weeks of Amenorrhea ( PROB-PROM Study)","PROB-PROM","Inclusion Criteria:\n\n* women ≥ 18 years of age;\n* mono-fetal pregnancy;\n* treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and \\\u003C 7 days in one of the study centers with expectant management;\n* speaking and able to read French or English.\n\nExclusion Criteria:\n\n* Presence of active labor;\n* Situation contraindicating expectant management (e.g., infection);\n* Significant malformation, chromosomal anomaly, or fetal death;\n* Signs of fetal distress;\n* Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;\n* Allergy to soy or lactose;\n* Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc.);\n* Vaginal probiotics intake 15 days before study inclusion;\n* Oral probiotic intake 30 days before study inclusion.",{"count":467,"type":23},80,[26],"The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT).\n\nSecondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups.\n\nTo achieve this, participants will be asked to:\n\n* Use the vaginal study product from the time of membrane rupture until delivery\n* Keep a diary documenting their symptoms and treatment adherence\n* Provide vaginal secretion samples and stool samples from their baby",[471,29,472],"Pregnancy","PPROM",[474,96,472,475,476],"pregnancy","vaginal probiotics","microbiota","2025-05-01",{"date":479,"type":34},"2025-05-11",{"date":481,"type":23},"2025-09-01",{"date":483,"type":23},"2026-05",{"name":485,"class":41},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":178,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":76},"100456407","the-effects-of-entrainment-on-respiratory-stability-and-cerebral-oxygenation-in-preterm-infants-100456407","NCT05223192","The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants","Inclusion Criteria:\n\n* Newborns born at 24-37 weeks' gestation at Mount Sinai hospital\n* Newborn is considered appropriate for clinically indicated music therapy\n\nExclusion Criteria:\n\n* Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)\n* Infant of uncertain viability (gestation \\\u003C23 weeks, birth weight \\\u003C500 grams)\n* Known or suspected genetic disorder (e.g., Trisomy 21)\n* Identified hearing disorder","37 Weeks",{"count":494,"type":23},118,[26],"Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention\u002Fsilence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.",[29],[499,500,96,501,502],"music therapy","ocean disc","vital signs","cerebral oxygenation","2025-04-04",{"date":505,"type":34},"2025-04-08",{"date":507,"type":34},"2022-04-01",{"date":509,"type":23},"2026-03-31",{"name":511,"class":41},"Icahn School of Medicine at Mount Sinai",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":18,"minAge":518,"maxAge":519,"enrollmentInfo":520,"targetDuration":4,"studyType":24,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":76},"100467005","prevention-of-developmental-delay-and-xylitol-pddax-study-100467005","NCT05361122","Prevention of Developmental Delay and Xylitol (PDDaX) Study","Inclusion Criteria:\n\n* Child born during the PPaX trial\n* Enrollment age between 4-8 years old\n* Parental or legal guardian consent obtained\n* Willing to undergo 3 neurodevelopmental tests\n* Willing to travel to BCMF for neurodevelopmental assessment\n* Assent by the pediatric subject for participation in the study\n\nExclusion Criteria:\n\n* Parent or legal guardian cognitively unable to provide consent\n* Child unwilling to provide assent to participate in the study","4 Years","8 Years",{"count":521,"type":23},1000,[26],"The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children.\n\nAdditionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes).\n\nThe researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.",[29,525],"Neurodevelopmental Disorders",[527,528,471,29],"Xylitol","Oral Health","2025-03-24",{"date":531,"type":34},"2025-03-27",{"date":533,"type":34},"2023-04-04",{"date":535,"type":23},"2027-08-31",{"name":108,"class":41},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":24,"phases":548,"briefSummary":549,"conditions":550,"keywords":556,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":76},"100585164","an-educational-intervention-to-improve-the-success-of-intubation-in-newborns-using-a-video-laryngoscope-by-reducing-the-time-the-procedure-takes-100585164","NCT06898801","An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.","Neonatal INtubation After \"Just-in-time\" Audiovisual Training: a Randomised Controlled Trial","NINJA","Inclusion Criteria:\n\nNeonates of any age or gestation who require endotracheal intubation in the Neonatal Intensive Care Unit in the National Maternity Hospital during the study period.\n\nExclusion Criteria:\n\n* Neonates with an upper airway malformation.\n* If it is deemed by the treating clinical team that the clinical scenario does not allow time for the intervention e.g. cardiac arrest","1 Year",{"count":547,"type":23},140,[26],"This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly.\n\nThe skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency.\n\nIn the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today.\n\nThe investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a \"Just-in-Time\" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a \"Just-in-Time\" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.",[551,552,553,29,554,555],"Respiratory Distress Syndrome, Newborn","Endotracheal Intubation","Neonatal Intubation Performance","Neonate","Education, Medical",[557,558,559],"Just-in-Time","Neonatal intubation","Teaching","2025-03-20",{"date":531,"type":34},{"date":563,"type":23},"2025-03",{"date":565,"type":23},"2027-05",{"name":567,"class":41},"University College Dublin",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":117,"minAge":118,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":578,"conditions":579,"keywords":582,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":76},"100579176","quality-of-information-provided-during-antenatal-consultations-100579176","NCT06820892","Quality of Information Provided During Antenatal Consultations","Evaluation of the Concordance Between the Information Delivered in Antenatal Diagnosis Consultation and Parents Experience After the Birth of Their Infant","EVIDANCE","Inclusion Criteria:\n\n* Patients were observed at the multidisciplinary prenatal diagnosis centre.\n* Patients who had attended at least one antenatal consultation with a pediatric neonatologist\n* Patients who gave birth between January 2020 and December 2022 and whose newborn was hospitalized in the neonatology department\n\nExclusion Criteria:\n\n* a child who died in hospital or had a condition with a high risk of death in the first few years of life\n* non-French speaking mothers\n* Mothers who were minors at the time of the study",{"count":577,"type":23},113,"The objective of this questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth.",[580,29,581],"Congenital Anomalies","Antenatal Consultation",[583,584,585],"Antenatal","Antenatal consultation","information","2025-02-10",{"date":588,"type":34},"2025-02-11",{"date":590,"type":34},"2024-08-02",{"date":592,"type":23},"2025-03-15",{"name":594,"class":41},"Hospices Civils de Lyon",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":602,"maxAge":179,"enrollmentInfo":603,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":76},"100432464","creating-a-calmer-nicu-optimizing-growth-and-brain-development-in-preterm-infants-100432464","NCT04911452","Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants","Creating a CALMER NICU: Pilot Testing a Robot for Optimizing Growth and Brain Development in Preterm Infants in the NICU","Inclusion Criteria:\n\n* Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period;\n* Infants who are on continuous positive airway pressure or are ventilated;\n* At least one parent\u002Fcaregiver must speak sufficient English to provide consent\n\nExclusion Criteria:\n\n* Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment;\n* Infants that have pre-existing cardiovascular instability defined by shock\u002Fhypotension\u002Fneed for cardiovascular drugs\n* Infants receiving paralytic drugs;\n* Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage\u002Fstroke);\n* Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.","26 Weeks",{"count":604,"type":23},30,[26],"Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff.\n\nThe goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased \"dose\" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total\u002Fday for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks).\n\nResearch questions:\n\nTrial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT?\n\nInfant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting\u002Fsleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?",[29],[29,609,610,611,612,187,613,614],"Neonatal intensive care","Growth","Robotic device","Skin-to-skin care","Brain activity","EEG","2024-12-31",{"date":617,"type":34},"2025-01-01",{"date":619,"type":34},"2021-09-27",{"date":621,"type":23},"2025-12-31",{"name":623,"class":41},"University of British Columbia",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":116,"sex":18,"minAge":632,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":24,"phases":636,"briefSummary":637,"conditions":638,"keywords":639,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":76},"100557400","best-practices-fo-early-diagnosis-of-cerebral-palsy-100557400","NCT06537622","Best Practices Fo Early Diagnosis of Cerebral Palsy","Implementation of Best Practices for Early Diagnosis of Cerebral Palsy (CP) in Very Preterm Infants: a Stepped-wedge Cluster Randomized Controlled Trial (RCT)","CP","Inclusion Criteria:\n\n* Infants born preterm at less than 29 weeks' GA and their parents\n* Admission to a Neonatal Intensive Care Unit (NICU) participating in the Canadian Neonatal Network (CNN).\n\nExclusion Criteria:\n\n* Death prior to first visit in clinic\n* Major congenital malformation and\u002For significant chromosomal defects affecting development beyond preterm birth\n* Child moved outside Canada prior to first visit in clinic.","2 Months","30 Months",{"count":635,"type":23},2000,[26],"In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e. what is being implemented) in neonatal follow-up clinics across Canada. This clinical practice guideline should be part of what neonatal follow-up specialists do in their routine clinical work with children born preterm. However, there is a wide variability in practice. The goal of this project is to harmonize practices in the neonatal follow-up community in agreement with international recommendations for earlier diagnosis of cerebral palsy. This research will measure if clinicians are truly following the clinical practice guideline. If not, implementation strategies that address barriers and leverage on facilitators will be deployed for successful uptake of the clinical practice guideline. This research will also assess whether implementation of the clinical practice guideline is associated with better patient outcomes.",[323,29],[640,641,642,643,644,645],"Corrected age","very preterm infants","Developmental functioning","Guideline","Diagnosis","Randomized controlled trial","2024-12-13",{"date":648,"type":34},"2024-12-18",{"date":650,"type":23},"2025-02-01",{"date":652,"type":23},"2028-11-01",{"name":654,"class":41},"St. Justine's Hospital",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":116,"sex":18,"minAge":4,"maxAge":118,"enrollmentInfo":662,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":664,"conditions":665,"keywords":666,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":139},"100418049","evaluating-wearable-smart-sensors-for-continuous-measurement-of-vital-signs-in-icu-patients-100418049","NCT04723654","Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU Patients","Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU","Inclusion Criteria-ICU Population:\n\n* Admitted to one of the four ICUs at Lurie Children's or Prentice Women's Hospital\n* Under 18 years of age\n\nInclusion Criteria-Non-ICU Population\n\n* Under 18 years of age\n* Willing to visit the Center for Autonomic Medicine in Pediatrics (CAMP) for a one time study visit\n\nExclusion Criteria-ICU Population:\n\n* A skin abnormality that would potentially increase the risk of device\n* 18 years of age or older\n* Determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family)\n\nExclusion Criteria-Non-ICU Population:\n\n* A skin abnormality that would potentially increase risk of device use\n* 18 years of age or older",{"count":663,"type":23},500,"The purpose of this study is to develop biocompatible wireless electronic devices that will allow continuous, non-invasive hemodynamic and physiology measurements in the ICU.",[29],[667,668,669],"Blood Pressure","Vital Signs","Wireless Monitoring","2024-11-25",{"date":672,"type":34},"2024-11-27",{"date":674,"type":34},"2018-03-15",{"date":676,"type":23},"2026-06-30",{"name":678,"class":41},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":686,"enrollmentInfo":687,"targetDuration":4,"studyType":24,"phases":689,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":76},"100558932","prophylactic-surfactant-by-thin-endotracheal-catheter-for-preterm-infants-at-birth-the-protect-trial-100558932","NCT06557551","Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial","proTeCt","Inclusion criteria\n\n* Infants of any sex born before 28 weeks of gestation\n* Clinicians plan to provide intensive care\n* Consent for their participation provided by parent(s)\u002Fguardian(s) before their birth\n\nExclusion criteria\n\n• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD\u002FPFO\u002FVSD\u002FPDA )","30 Minutes",{"count":688,"type":23},164,[26],"The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life.\n\nThe main question it aims to answer is:\n\nDo fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth?\n\nExtremely premature babies who are receiving breathing support through a face mask will either:\n\n* Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or\n* Continue on face mask breathing support.\n\nAll babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.",[692,29,693,694],"Infant, Newborn, Diseases","Prematurity; Extreme","Respiratory Distress Syndrome in Premature Infant","2024-10-08",{"date":697,"type":34},"2024-10-15",{"date":699,"type":34},"2024-08-19",{"date":701,"type":23},"2027-02-28",{"name":567,"class":41}]