[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-birth\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-birth":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,43,75,111,143,171,201,232,257,281,307,346,372,402,426,450,473,501,537,571,596,622,646,667,692],{"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},"100415109","effect-of-the-ibaip-in-preterm-infants-neurodevelopment-100415109",false,"NCT04685356","Effect of the IBAIP in Preterm Infants Neurodevelopment","Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age","IBAIP","Inclusion Criteria :\n\n* Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.\n* Written informed consent of at least one of the parents \u002F legal guardian or 2 parents \u002F legal guardians depending on the family context\n* Normal neurological examination between 36 and 41 weeks of corrected age\n\nExclusion Criteria:\n\n* Intraventricular hemorrhage (III or IV), periventricular leukomalacia\n* Brain MRI abnormalities performed after 36 weeks of corrected age\n* Life-threatening pathology\n* Severe congenital abnomality\n* Severe maternal pathology (physical and \u002F or mental)\n* Parents whose native language is not French\n* Participation in another interventional study on the management of post-hospital neurodevelopment disorders","ALL","25 Weeks","32 Weeks",{"count":22,"type":23},240,"ESTIMATED","INTERVENTIONAL",[26],"NA","Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.\n\nThese neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.\n\nPost-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.\n\nEarly interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.\n\nThe IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.",[29],"Premature Birth","RECRUITING","2026-06-24",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":34},"2022-11-08",{"date":38,"type":23},"2028-01-08",{"name":40,"class":41},"University Hospital, Brest","OTHER",9,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100641672","systematic-screening-of-lower-genital-tract-infections-100641672","NCT07592286","Systematic Screening of Lower Genital Tract Infections","Systematic Screening of Lower Genital Tract Infections in Pregnant Women for Gestational and Neonatal Outcomes: a Randomized Controlled Trial","Inclusion Criteria:\n\n* First-trimester pregnant women.\n* Receiving care at the Women's Health service.\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n#No specific exclusion criteria.\n\nThe study has not started yet and no participants have been enrolled. The term \"low-risk\" was removed because the study will recruit pregnant women in general","FEMALE","12 Years",{"count":53,"type":23},250,[26],"Introduction: The investigation of systematic screening for asymptomatic genital infections in pregnant women is justified by the relevance of these conditions in determining adverse neonatal outcomes, such as prematurity, low birth weight, and perinatal morbidity and mortality. Despite its importance, previous studies have shown inconsistent results, largely due to methodological limitations related to sample size, lack of standardized treatment protocols, and insufficient follow-up of pregnant women. There is also divergence among national and international guidelines, which vary between universal and selective recommendations, highlighting gaps in the standardization of clinical practices.\n\nObjectives: To investigate the effectiveness of implementing systematic screening protocol for asymptomatic genital infections in pregnant women in preventing adverse gestational and neonatal outcomes. The specific objectives are: to identify the most prevalent infections in this group; to evaluate the relationship between treatment and the incidence of complications; to compare outcomes between participants assigned to systematic screening and those receiving standard care and to propose recommendations for clinical practice and health policies based on a critical review of the literature and the results obtained.\n\nMethods: This is a randomized controlled trial that will recruit 250 pregnant women, followed from the first trimester until delivery. Participants will be randomized into two groups: an intervention group, undergoing systematic screening with protocol-guided treatment, and a control group, managed according to current standard care practices, following the municipality's protocol for screening and treatment of genital infections. Primary outcomes include preterm birth, preterm premature rupture of membranes, low birth weight, intra-amniotic infection, puerperal infection, neonatal infection, and fetal and neonatal mortality. Statistical analysis will follow the intention-to-treat principle, and differences in outcomes between groups will be estimated.\n\nExpected Results: This study is expected to provide evidence on whether systematic screening reduces (or does not reduce) maternal and neonatal complications. The randomized controlled trial will be prospectively registered prior to the enrollment of the first participant, in accordance with current ethical standards.\n\n\\*\\* The study has not started yet and no participants have been enrolled. The term \"low-risk\" was removed because the study will recruit pregnant women in general",[57,58,29,59,60],"Neonatal Outcomes","Pregnancy Complications, Infectious","Premature Rupture of Fetal Membranes","Pregnancy",[62,63,64],"screening","lower genital tract infections","pregnancy","NOT_YET_RECRUITING","2026-06-15",{"date":68,"type":34},"2026-06-17",{"date":70,"type":23},"2026-07-15",{"date":72,"type":23},"2028-12-30",{"name":74,"class":41},"Universidade Federal do Pampa",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100636779","phase-1-pharmacokinetics-and-placental-transfer-of-caffeine-100636779","NCT07570121","Pharmacokinetics and Placental Transfer of Caffeine","Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy","AnteCaff","Inclusion Criteria:\n\n1. Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before delivery.\n2. Informed consent provided for participation.\n3. Cesarean delivery.\n\nExclusion Criteria:\n\n1. Known major fetal congenital anomalies or genetic disorders.\n2. Plan in place for limited neonatal resuscitation or comfort care only.\n3. Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.\n4. Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.\n5. Fetal arrhythmia.\n6. Seizure disorder.\n7. Oligohydramnios due to renal anomalies or renal impairment.\n8. Current or anticipated use of products that include sodium benzoate.\n9. Maternal age \\\u003C18 years.\n10. Maternal medical conditions in which caffeine or other stimulants would be contraindicated.\n11. High likelihood of receiving terbutaline.\n12. Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.\n13. Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study.","18 Years",{"count":85,"type":23},30,[87],"PHASE1","The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.",[90,29,91,92,93],"Preterm Labor With Preterm Delivery","Apnea of Prematurity","Respiratory Distress Syndrome","Bronchopulmonary Dysplasia",[95,96,97,98,99,100],"caffeine","preterm labor","prematurity","pharmacokinetics","bronchopulmonary dysplasia","apnea of prematurity","2026-06-03",{"date":103,"type":34},"2026-06-04",{"date":105,"type":34},"2026-06-01",{"date":107,"type":23},"2027-06",{"name":109,"class":41},"Indiana University",1,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":50,"minAge":83,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":24,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100518892","late-cerclage-in-high-risk-pregnancies-latch-100518892","NCT06036446","LATe Cerclage in High-risk Pregnancies (LATCH)","Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial","LATCH","Inclusion Criteria:\n\n* 18-50 years old, pregnant, assigned female at birth\n* Singleton pregnancy\n* TVU CL ≤25mm between 24 0\u002F7 - 26 6\u002F7 weeks of gestation\n\nExclusion Criteria:\n\n* Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed \\>14 weeks, or cotwin pregnancy loss diagnosed \\>14 weeks\n* Cerclage in situ\n* Preterm labor, defined as painful regular uterine contractions and change in cervical dilation\n* PPROM\n* Active vaginal bleeding\n* Suspected intraamniotic infection\n* Major fetal structural abnormality or chromosomal disorder\n* Placenta previa or accreta\n* Other contraindication to cerclage placement\n* Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone",true,"50 Years",{"count":122,"type":23},329,[26],"The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0\u002F7-26 6\u002F7 weeks.",[29],[127,128,129,130,131,132],"Cervical length","Short cervix","Shortened cervix","Prematurity","Preterm birth","Viability","2026-05-27",{"date":135,"type":34},"2026-05-29",{"date":137,"type":34},"2023-11-10",{"date":139,"type":23},"2029-02",{"name":141,"class":41},"Thomas Jefferson University",2,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":150,"maxAge":19,"enrollmentInfo":151,"targetDuration":4,"studyType":24,"phases":153,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":110},"100640203","probiotics-supplementation-for-neurodevelopment-in-preterm-infants-100640203","NCT07617181","Probiotics Supplementation for Neurodevelopment in Preterm Infants","Effect of Gut Microbiota Remodeling Via Probiotics Supplementation on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)\n* Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).\n* Corrected age of 6 months ± 7days at the time of enrollment.\n* No systemic antibiotic usage within 14 days prior to screening.\n* Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.\n\nExclusion Criteria:\n\n* Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).\n* Severe neurological disorders or structural brain injuries (e.g., Grade III\u002FIV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).\n* Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).\n* Concurrent participation in other interventional clinical trials.\n* Planned long-term use of other commercial probiotic\u002Fprebiotic supplements outside the study protocol during the intervention period.\n* High risk of loss to follow-up (e.g., expected relocation).","23 Weeks",{"count":152,"type":23},116,[26],"The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure. The intervention lasts for 6 months. The study hypothesizes that early gut microbiota remodeling via exogenous probiotics can improve neurodevelopment. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \\& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids \\[SCFAs\\], and systemic inflammatory markers.",[29,156,157],"Neurodevelopmental Disorders","Dysbiosis",[159,160,161,162],"Probiotics","Gut-Brain Axis","Neonatal Antibiotic Exposure","Preterm Infants","2026-05-23",{"date":105,"type":34},{"date":166,"type":23},"2026-06",{"date":168,"type":23},"2027-12",{"name":170,"class":41},"Fudan University",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":24,"phases":180,"briefSummary":181,"conditions":182,"keywords":187,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100459604","the-periviable-goals-decision-support-tool-100459604","NCT05264779","The Periviable GOALS Decision Support Tool","Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool","Inclusion Criteria for Pregnant Persons:\n\n* Adults (18 years or older)\n* Pregnant between 22 0\u002F7 to 25 6\u002F7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution).\n* Presenting to Labor \\& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction).\n* Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team.\n\nInclusion Criteria for Important Others:\n\n* Adults (18 years or older)\n* 1 per pregnant person\n* Is identified by the pregnant person as someone who will be involved in making decisions for the baby\n* Must be present at the time of randomization to participate\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Incarcerated\n* Medically unstable (i.e. in active labor and dilated 6cm or more)\n* Emotionally unstable\n* Have not been counseled by their healthcare team regarding neonatal treatment options\n* Are not admitted to Labor \\& Delivery for reasons indicative of a threatened early delivery\n* If they are experiencing a known fatal fetal anomaly\n* Are not present at the time of randomization (only for important others)",{"count":179,"type":23},300,[26],"The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0\u002F7 - 25 6\u002F7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.",[183,29,184,185,186],"Pregnancy Preterm","Pregnancy Complications","Obstetric Labor, Premature","Obstetric Labor Complications",[188,189,131,190,191],"Decision making","Periviable delivery","Risk Communication","Neonatal Resuscitation","2026-05-06",{"date":194,"type":34},"2026-05-11",{"date":196,"type":34},"2022-06-06",{"date":198,"type":23},"2027-02",{"name":109,"class":41},12,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":24,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100640472","bed-rest-with-a-short-cervix-on-preterm-birth-100640472","NCT07577388","Bed Rest With a Short Cervix on Preterm Birth","BEWISE - Bed Rest With a Short Cervix on Preterm Birth","BEWISE","Pregnant women with gestational age 20+0 to 33+6\n\n* Cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies\n* Above 18 years of age\n* Reads and understands Danish or English",{"count":210,"type":23},6000,[26],"Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.\n\nThe use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects.\n\nThe overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR).\n\nThe primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix.\n\nSecondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density.\n\nThrough the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria.\n\nThe primary outcome is gestational age in days (continuous).",[214,215,216,184,217,218,219,220,221,29,185,222,223],"Preterm Birth","Cervical Insufficiency","Bed Rest","Immobilization","Depression, Postpartum","Pregnancy Outcome","Infant, Premature","Uterine Cervical Incompetence","Physical Activity","Bone Density","2026-05-03",{"date":194,"type":34},{"date":227,"type":23},"2026-05-01",{"date":229,"type":23},"2029-05-01",{"name":231,"class":41},"Julie Glavind",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":239,"studyType":242,"phases":4,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":5},"100491946","multisite-inventory-of-neonatal-perinatal-interventions-mini-minimum-dataset-100491946","NCT05685745","Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset","Inclusion Criteria:\n\n* All local births with gestational ages of 22 weeks 0 days - 23 weeks 6 days, regardless of pregnancy outcome or neonatal intensive care (NICU) admission; AND\n* All outborn NICU admissions with gestational age at birth of 22 weeks 0 days - 23 weeks 6 days\n* Optional: Centers who desire to include data for NICU admissions of infants born \\\u003C22 weeks' gestation may also submit these data.","0 Years","1 Year",{"count":241,"type":23},5000,"OBSERVATIONAL","The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.",[245,185,29,246,247],"Infant, Extremely Premature","Intensive Care, Neonatal","Intensive Care Units, Neonatal","2026-04-28",{"date":250,"type":34},"2026-05-04",{"date":252,"type":34},"2019-01-01",{"date":254,"type":23},"2030-01-01",{"name":256,"class":41},"The University of Texas Health Science Center, Houston",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":24,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":110},"100565547","healing-tiny-minds-rural-recovery-through-virtual-and-lived-experience-care-100565547","NCT06643598","Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care","Inclusion Criteria:\n\n1. IPNH-NDCP patients, including:\n\n   * Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or\n   * premature children (born at less than 28 weeks gestational age).\n2. Parent or legal guardian will also be enrolled as a participant\n3. Parents must be English-speaking (able to provide consent and complete questionnaires).\n\nExclusion Criteria:\n\n1. Not suitable for study participation due to other reasons at the discretion of the investigator.\n2. Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.\n3. Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.\n4. For parents or legal guardians, there are no exclusion criteria.","5 Years",{"count":265,"type":23},225,[26],"The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and\u002For premature birth produces the same effects as when administered at in-person facilities.",[269,29,270,271],"Hypoxic Ischaemic Encephalopathy (HIE)","Cerebral Palsy","Neurological Disorder","2026-03-24",{"date":274,"type":34},"2026-03-27",{"date":276,"type":34},"2025-06-03",{"date":278,"type":23},"2030-03",{"name":280,"class":41},"University of Wisconsin, Madison",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":18,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100558699","phase-4-pragmatic-evaluation-of-respiratory-distress-syndrome-treatment-in-africa-100558699","NCT06554522","Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa","Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa","Inclusion Criteria:\n\n* Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.\n* Silverman Anderson Score ≥5 before or after CPAP treatment.\n* Admitted to a study site within 24 hours of life.\n\nExclusion Criteria:\n\n* Major congenital or genetic anomalies.\n* Active pulmonary hemorrhage.\n* Major craniofacial anomalies that preclude the successful use of CPAP","1 Hour","24 Hours",{"count":291,"type":23},1512,[293],"PHASE4","The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:\n\nDoes surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?\n\nResearchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.\n\nParticipants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:\n\nReceive surfactant replacement therapy by the less invasive surfactant administration technique.\n\nBe monitored for complications Be followed throughout their hospitalization to determine their survival rate.",[296,297,298,29],"Respiratory Distress Syndrome in Premature Infant","RDS of Prematurity","Surfactant Deficiency Syndrome Neonatal","2026-03-23",{"date":274,"type":34},{"date":302,"type":34},"2025-01-01",{"date":304,"type":23},"2027-12-30",{"name":109,"class":41},8,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":83,"enrollmentInfo":315,"targetDuration":83,"studyType":242,"phases":4,"briefSummary":317,"conditions":318,"keywords":322,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":110},"100630687","neonatal-data-and-biobank-to-study-factors-influencing-development-in-preterm-infants-born-at-32-weeks-gestation-andor-1500-g-birth-weight-100630687","NCT07490912","Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at \u003C32 Weeks' Gestation and\u002For \u003C1500 g Birth Weight","Establishing a Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at \u003C32 Weeks' Gestation and\u002For \u003C1500 g Birth Weight","Neo-Life","Inclusion Criteria:\n\n* Preterm infants born \\\u003C32 weeks' gestational age and\u002For with a birth weight \\\u003C 1500 g\n* Informed consent of parents\u002F legal guardians\n\nExclusion Criteria:\n\n* none",{"count":316,"type":23},1300,"The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and\u002For a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions.\n\nThe primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems.\n\nThe study population includes infants born with a gestational age of less than 32 weeks and\u002For a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants.\n\nBy combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.",[319,320,321,29],"Preterm Infant Development","Preterm Infant Health","Prematurity Complications",[97,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337],"preterm infants","very low birth weight infants","very preterm infants","gestational age \u003C32 weeks","Premature birth","\u003C32 weeks gestational age","very low birth weight","\u003C1500 g birth weight","database","biobank","preterm infant development","preterm infant health","preterm infant long-term outcome","prematurity complications","risk and protective factors of preterm infant development","2026-03-18",{"date":272,"type":34},{"date":341,"type":23},"2026-03-13",{"date":343,"type":23},"2056-03-13",{"name":345,"class":41},"University Hospital of Cologne",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":119,"sex":50,"minAge":353,"maxAge":354,"enrollmentInfo":355,"targetDuration":239,"studyType":242,"phases":4,"briefSummary":357,"conditions":358,"keywords":362,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":110},"100285569","pprom-registry-preterm-premature-rupture-of-membranes-100285569","NCT02997345","PPROM Registry (Preterm Premature Rupture of Membranes)","Patient Registry for Women Diagnosed With Preterm Premature Rupture of Membranes or PPROM During Pregnancy","Inclusion Criteria:\n\n* Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy\n\nExclusion Criteria:\n\n* Those without a clinical diagnosis or confirmation of PPROM in pregnancy\n* Diagnosis of PROM beyond 37 weeks of pregnancy","14 Years","55 Years",{"count":356,"type":23},3000,"Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.",[359,360,361,29],"Fetal Membranes, Premature Rupture","Preterm Premature Rupture of the Membranes","Oligohydramnios",[363],"PPROM",{"date":365,"type":34},"2026-03-16",{"date":367,"type":34},"2013-07",{"date":369,"type":23},"2030-12",{"name":371,"class":41},"American Alliance for pProm Support",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":18,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":24,"phases":383,"briefSummary":384,"conditions":385,"keywords":388,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":4},"100625144","infant-massage-for-lymphedema-and-comfort-in-preterm-newborns-100625144","NCT07418814","Infant Massage for Lymphedema and Comfort in Preterm Newborns","The Effectiveness of Infant Massage in Reducing Immobilization-Related Lymphedema Symptoms and Increasing Comfort in Preterm Newborns","Inclusion Criteria:\n\nTo ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited:\n\n* Clinical diagnosis of lymphedema.\n* Hemodynamic and clinical stability.\n* No current or recent (within 24 hours) administration of analgesic or sedative medications that could mask comfort assessments.\n* Intact skin integrity with no contraindications for topical massage.\n* Absence of congenital heart disease or neurological disorders (antenatal or postnatal diagnosis).\n* No immediate requirement for endotracheal aspiration.\n* Requirement for only non-invasive respiratory support (e.g., nCPAP).\n* Provision of written informed consent by the legal guardians (parents).\n\nExclusion Criteria:\n\nInfants will be excluded if they present with:\n\n* Major congenital anomalies.\n* Severe respiratory, cardiac, or neurological instability during the study period.\n* Any acute medical contraindication identified by the attending neonatologist.","28 Weeks","37 Weeks",{"count":382,"type":23},40,[26],"This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement.\n\nThe study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.",[386,29,387,217],"Lymphedema","Edema",[389,390,386,391,392,217],"Infant Massage","Preterm Infant","Neonatal Comfort","Massage Therapy","2026-02-11",{"date":395,"type":34},"2026-02-18",{"date":397,"type":23},"2026-04-01",{"date":399,"type":23},"2027-04-01",{"name":401,"class":41},"Erzurum Technical University",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":119,"sex":18,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":110},"100624766","biomarkers-study-in-infants-with-prior-neonatal-brain-injury-100624766","NCT07413900","Biomarkers Study in Infants With Prior Neonatal Brain Injury","Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury","Inclusion Criteria:\n\n* Child-parent dyads will be recruited to the study.\n* Children 3-24 months with and without a history of a perinatal brain injury (PBI) will be included in this study.\n* Children with PBIs will include:\n\n  * Children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,\n  * Children born at a premature gestational age (born at less than 32 weeks gestational age).\n  * Children diagnosed with cerebral palsy\n* Healthy control participants meeting inclusion criteria will include:\n\n  * healthy infants with no prior neurological (brain disorder) history\n* For all parents: the only research inclusion criteria is to be the parent or legal guardian of a newborn with perinatal brain injury or healthy control participant.\n\nExclusion Criteria:\n\n* Healthy infants to be included in the control group will not have:\n\n  * a prior history of brain injury\n  * a diagnosis of cerebral palsy\n  * a history of a neurological disorder\n  * prior admission to the Neonatal Intensive Care Unit (NICU)\n* Children with chromosomal abnormalities, genetic syndromes and major congenital malformations will be excluded from both the patient groups and the control group.\n* Parents will have no exclusionary criteria.","3 Months","24 Months",{"count":412,"type":23},100,"This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete in-person games and assessments at UW-Madison University Hospital. Children will also take part in an EEG assessment. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home.",[415,416,29,417],"HIE - Hypoxic - Ischemic Encephalopathy","Perinatal Anoxic-ischemic Brain Injury","Healthy Participants","2026-02-09",{"date":420,"type":34},"2026-02-17",{"date":422,"type":34},"2023-03-13",{"date":424,"type":23},"2030-03-15",{"name":280,"class":41},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":119,"sex":18,"minAge":433,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":24,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":110},"100548160","tavns-paired-breastfeeding-to-improve-breastfeeding-at-discharge-100548160","NCT06417385","taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge","Inclusion Criteria:\n\n* Infants ≥ 35 weeks post-menstrual age,\n* Clinically stable, without significant respiratory support,\n* Deemed safe to breastfeed by OT\u002FSLP\u002Flactation,\n* Maternal interest in breastfeeding,\n* Are not breastfeeding well despite the assistance of a lactation consultant.\n\nExclusion Criteria:\n\n* Cardiomyopathy,\n* Unstable bradycardia,\n* Significant respiratory support,\n* Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia,\n* Maternal HIV without adequate viral suppression,\n* Maternal illicit drug use.","35 Weeks",{"count":435,"type":23},10,[26],"Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities.\n\nIf the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.",[29,439,440],"Breastfeeding, Exclusive","Feeding; Difficult, Newborn","2026-02-04",{"date":443,"type":34},"2026-02-06",{"date":445,"type":34},"2024-02-01",{"date":447,"type":23},"2027-06-01",{"name":449,"class":41},"Medical University of South Carolina",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":110},"100413282","mueller-polarimetric-colposcopy-for-high-performance-detection-of-cervical-changes-during-pregnancy-100413282","NCT04661553","Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy","Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)","COLPOTERME","Inclusion Criteria:\n\n* Major patient.\n* Single pregnancy.\n* Baseline ≥ 20 amenorrhea week for group 1 and baseline ≥ 20 amenorrhea week and \\\u003C37 amenorrhea week for group 2.\n* Dating obtained by ultrasound of the 1st trimester.\n* Written and informed consent.\n\n  * Group 1 (low risk):\n\nAsymptomatic patient benefiting from usual follow-up in the maternity hospital.\n\n\\> Group 2 (high risk): Symptomatic patient with cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of \\\u003C20mm.\n\nAsymptomatic patient with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of \\\u003C20mm.\"\n\nExclusion Criteria:\n\n* Known uterine malformation or suspected uterine malformation.\n* Pregnancy circled.\n* Premature rupture of membranes.\n* Suspicion of chorioamnionitis.\n* Abundant active bleeding hindering the visualization of the cervix.\n* History of conization.\n* Imminent childbirth.\n* Known medical indication at a birth \\\u003C37 amenorrhea week (severe pre-eclampsia, severe intrauterine growth retardation, hemorrhagic placenta previa, fetal malformations,….).\n* Examination of the cervix under speculum not possible.\n* Lack of social coverage (AME).\n* Limited understanding.\n* Participation in another intervention research.\n\n  \\> Group1 (Low risk):\n* History of spontaneous premature labor.\n* History of late miscarriage.\n* History of premature rupture of membranes.\"",{"count":459,"type":23},683,[26],"Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age. The uterine cervix's polarimetric analysis could make it possible to accurately predict the term of childbirth and be used as a screening tool for preterm birth.",[463,29],"Pregnancy Related","2026-01-19",{"date":466,"type":34},"2026-01-21",{"date":468,"type":34},"2020-12-22",{"date":470,"type":23},"2026-12",{"name":472,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":119,"sex":18,"minAge":481,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":24,"phases":485,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":110},"100469775","impact-of-moderate-preterm-birth-on-vocabulary-acquisition-100469775","NCT05397197","Impact of Moderate Preterm Birth on Vocabulary Acquisition","A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition","BABYLANG","Inclusion Criteria:\n\n* Infants born prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeks gestational age, GA)\n* Birth weight appropriate to gestational age determined by WHO growth charts (weight, height, head circumference)\n* Normal clinical examination at inclusion.\n* Written informed consent obtained from both parents (or single parent if single parent)\n* Infant with at least one parent who speaks and understands fluent French\n* Infant is affiliated with the social security system\n* Infant whose parents reside in Marseille\n\nExclusion Criteria:\n\n* Neonatal distress (Apgar score \\\u003C 7)\n* Hypoxic and ischemic encephalopathy\n* Perinatal acidosis\n* Intrauterine growth retardation\n* Brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia)\n* Cerebral congenital malformations\n* Neonatal epilepsy\n* Any condition that in the opinion of the investigator would not be compatible with the conduct of this study\n* Abnormal hearing test performed as part of the child's routine care at birth,","0 Days","2 Years",{"count":484,"type":23},160,[26],"Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea.\n\nIn our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. This work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding.\n\nThe identification of markers to predict language development is essential for the screening of these children at risk of language delay. These children could thus benefit from early adapted care even before the appearance of language deficits.",[29],[489,97,490,491],"speech acquisition","sounds processing","EEG","2026-01-07",{"date":494,"type":34},"2026-01-08",{"date":496,"type":34},"2022-10-19",{"date":498,"type":23},"2030-10-19",{"name":500,"class":41},"Assistance Publique Hopitaux De Marseille",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":354,"enrollmentInfo":509,"targetDuration":4,"studyType":24,"phases":511,"briefSummary":512,"conditions":513,"keywords":515,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":7},"100448026","phase-4-single-dose-of-antenatal-corticosteroids-for-pregnancies-at-risk-of-preterm-delivery-snacs-100448026","NCT05114096","Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)","Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe","SNACS","Inclusion Criteria:\n\n1. Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and \\\u003C34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours\n2. Capable of giving informed, written consent.\n\nExclusion Criteria:\n\n1. Contraindication to corticosteroids\n2. Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).\n3. Previous participation in this trial (in a previous pregnancy)\n4. Known severe\u002Flife-threatening fetal or pregnant patient condition (e.g. fetal congenital\u002Fchromosomal abnormality)\n5. Demise of one or more fetuses after 14 weeks and 0 days",{"count":510,"type":23},3254,[293],"Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.\n\nThe standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity.\n\nThe investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.",[214,29,514,185,184],"Complication of Prematurity",[327,131,516,517,518,519,520,521,522,523,524,525,526,527,528],"Obstetric labour","Betamethasone","Betamethasone Valerate","Betamethasone-17,21-dipropionate","Betamethasone benzoate","Betamethasone sodium phosphate","Anti-Inflammatory Agents","Glucocorticoids","Hormones","Hormones, Hormone Substitutes and Hormone Antagonists","Physiological Effect of Drugs","Anti-Asthmatic Agents","Respiratory System Agents","2026-01-05",{"date":492,"type":34},{"date":532,"type":34},"2023-07-20",{"date":534,"type":23},"2029-12-31",{"name":536,"class":41},"McMaster University",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":119,"sex":18,"minAge":545,"maxAge":546,"enrollmentInfo":547,"targetDuration":4,"studyType":24,"phases":549,"briefSummary":550,"conditions":551,"keywords":558,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":110},"100616529","the-effect-of-piomi-and-chronobiological-nutrition-on-readiness-for-feeding-full-transition-to-oral-feeding-and-body-weight-100616529","NCT07306793","The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight","The Effect of Oral Motor Intervention and Chronobiological Approach to Feeding Models Applied to Preterm Infants on Infants' Readiness to Feed, Transition to Total Oral Feeding, and Body Weight","PIOMI","Inclusion Criteria:\n\n* Preterm infants with a postnatal age of 29-33 weeks,\n* Whose vital signs and clinical condition have been stable for at least 24 hours,\n* Whose APGAR score at 1 and 5 minutes (Activity-Pulse-Grimace-Appearance-Respiration) is 4 or higher.\n\nExclusion Criteria:\n\n* Infants with major congenital anomalies (such as congenital heart disease, cleft palate, cleft lip) or birth trauma,\n* Infants with RDS,\n* Infants diagnosed with asphyxia,\n* Infants with intraventricular hemorrhage,\n* Infants with Neonatal Withdrawal Syndrome,\n* Infants with Fetal Alcohol Syndrome,\n* Infants included in the study group who develop any complications or whose stable condition deteriorates during the follow-up period,\n* Infants with feeding intolerance or who are interrupted from feeding for more than 48 hours,\n* Infants who develop sepsis,\n* Infants who develop necrotizing enterocolitis,\n* Infants receiving mechanical ventilation support,\n* Infants who receive narcotic analgesia or sedation,","29 Weeks","33 Weeks",{"count":548,"type":23},54,[26],"This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.",[552,553,554,555,556,557,29],"Neonatal İntensive Care","Nutrition With A Chronobiological Approach","Readiness For Feding","Body Weight","Breast Milk","Nutrition",[552,553,554,555,559,560,561],"Transitioning To Total Oral Feeding","Premature Infant Oral Motor Intervention (PIOMI)","Prematüre","2026-01-01",{"date":564,"type":34},"2026-01-06",{"date":566,"type":34},"2025-03-01",{"date":568,"type":23},"2026-09-30",{"name":570,"class":41},"Aydin Adnan Menderes University",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":120,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":110},"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",{"count":579,"type":23},311,[293],"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.",[58,29,583,584,585,130],"Neonatal Diseases and Abnormalities","Antibiotic Prophylaxis","Latency Period","2025-12-10",{"date":588,"type":34},"2025-12-18",{"date":590,"type":34},"2025-09-10",{"date":592,"type":23},"2029-07-31",{"name":594,"class":595},"Sheba Medical Center","OTHER_GOV",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":621},"100348679","optimizing-family-counseling-for-anticipated-extremely-preterm-delivery-100348679","NCT03819933","Optimizing Family Counseling for Anticipated Extremely Preterm Delivery","1. Pregnant women and their partners\n\n   Inclusion Criteria:\n   * English-proficient adult pregnant woman admitted between 22 0\u002F7-25 6\u002F7 weeks' estimated gestation for anticipated extremely preterm delivery and her adult partner (if available) for whom an antenatal neonatal intensive care unit (NICU) consultation was requested and performed\n\n   Exclusion Criteria:\n   * Non-English proficient\n   * Fetal congenital malformation(s)\n   * \\\u003C18y old\n   * \\\u003C22 0\u002F7 or \\> 25 6\u002F7 weeks' estimated gestation\n   * Repeat consultation\n2. Counseling MFM and Neonatology providers\n\nInclusion Criteria:\n\n* Practicing MFM or Neonatology provider (attending, fellow, resident, practitioner or RN) from the 3 participating sites: Brigham \\& Women's Hospital (BWH), Beth Israel Deaconess Medical Center (BIDMC), South Shore Hospital (SSH)\n\nExclusion Criteria:\n\n* None","99 Years",{"count":604,"type":23},460,[26],"Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills.",[608,29],"Preterm Pregnancy",[610,611],"Counseling","Extreme Prematurity","2025-12-08",{"date":614,"type":34},"2025-12-16",{"date":616,"type":34},"2019-09-17",{"date":618,"type":23},"2027-02-28",{"name":620,"class":41},"Boston Children's Hospital",3,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":50,"minAge":83,"maxAge":4,"enrollmentInfo":630,"targetDuration":239,"studyType":242,"phases":4,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":142},"100542292","air-pollution-and-pregnancy-100542292","NCT06340971","Air Pollution and Pregnancy","The Effects of Air Pollution on Pregnancy and Adverse Birth Outcomes","PTB","Inclusion Criteria:\n\n* We aim to include data from pregnant women who delivered at University College London Hospitals from 2019 onwards after the start of the EPIC electronic patient record. The is no specified age range for this study, so as to improve inclusivity. We also aim to represent minority ethnic groups and patients with social deprivation within our dataset.\n\nExclusion Criteria:\n\n* We will exclude data from patients with an incomplete duration of follow-up due to transfer of antenatal care for delivery at another trust. Patients with incomplete past obstetric history data, inaccurate estimations of gestational age (e.g. due to late booking of the pregnancy) and missing data for 'postcode of usual address' will also be excluded. Patients who are less than 18 years of age will be excluded.",{"count":631,"type":23},200000,"We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth.\n\nWe aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact.",[29],[131,60,327,635,636],"Air pollution","Air quality","2025-11-21",{"date":639,"type":34},"2025-11-24",{"date":641,"type":34},"2024-11-01",{"date":643,"type":23},"2029-11-30",{"name":645,"class":41},"Queen Mary University of London",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":119,"sex":18,"minAge":4,"maxAge":652,"enrollmentInfo":653,"targetDuration":4,"studyType":24,"phases":655,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":665,"locationsCount":110},"100611162","evaluation-of-the-health-effects-of-the-air-purifier-in-preterm-infants-after-discharge-100611162","NCT07236996","Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge","Inclusion Criteria:Children aged 0 to 6 years who were born at less than 37 weeks of gestation.\n\n\\-\n\nExclusion Criteria:Children born at more than 37 weeks of gestation.\n\n\\-","6 Years",{"count":654,"type":23},180,[26],"Participant's baby was born prematurely and had underdeveloped lungs at birth. Most premature infants require mechanical ventilation after birth, which increases the risk of lung injury and may lead to varying degrees of bronchopulmonary dysplasia (BPD). Investigators believe that introducing an air purifier into your home environment after Participant's baby is discharged could help improve their lung development.\n\nThis study aims to non-invasively measure baby's transcutaneous carbon dioxide (PtcCO₂) levels and blood oxygen saturation (SpO₂) at home, both with and without the use of an air purifier. In addition, investigators will collect data from Kaohsiung Medical University Hospital medical records regarding the number of visits, respiratory status, height, weight, head circumference, and developmental progress. Health questionnaires will also be administered to assess changes in health outcomes and provide recommendations on improving indoor air quality in Participant's home.",[658,29],"Premature - Weight 1000g-2499g or Gestation of 28-37weeks","2025-11-17",{"date":661,"type":34},"2025-11-19",{"date":663,"type":34},"2021-05-21",{"date":166,"type":23},{"name":666,"class":41},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":50,"minAge":674,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":24,"phases":677,"briefSummary":678,"conditions":679,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":110},"100556154","postpartum-care-in-the-nicu-pelican-transitions-100556154","NCT06521398","Postpartum Care in the NICU (PeliCaN) Transitions","PeliCaN","Inclusion Criteria:\n\n* HUP postpartum patients who are at least 16 years old at the time their newborns' birth\n* Infant born at HUP\n* Preterm birth \\\u003C34 weeks\n* English language speaking\n\nExclusion Criteria:\n\n* Unable to read or sign informed consent\n* Parents of infants transferred into HUP NICU\n* If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks\n* HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth","16 Years",{"count":676,"type":23},20,[26],"This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.",[680,29,681,682],"Stress Disorders, Post-Traumatic","Postpartum Depression","Postpartum Anxiety","2025-10-09",{"date":685,"type":34},"2025-10-14",{"date":687,"type":34},"2024-09-11",{"date":689,"type":23},"2027-08",{"name":691,"class":41},"University of Pennsylvania",{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":696,"acronym":4,"eligibilityCriteria":697,"healthyVolunteers":119,"sex":18,"minAge":20,"maxAge":433,"enrollmentInfo":698,"targetDuration":4,"studyType":24,"phases":700,"briefSummary":701,"conditions":702,"keywords":703,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":142},"100520942","development-of-a-therapeutic-device-to-improve-speech-sound-differentiation-in-preterm-infants-100520942","NCT06063122","Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants","Inclusion Criteria:\n\n* CGA 32 0\u002F7-35 0\u002F7 weeks at study start, and GA 35 0\u002F7 weeks at birth\n\nExclusion Criteria:\n\n* Ventilation using an endotracheal tube, major congenital malformations, family history of genetic hearing loss, and use of sedative\u002Fseizure medications (medications potentially masking ERP measured sensory processing) and severe white matter injury as it increases the likelihood of hearing deficits.",{"count":699,"type":23},203,[26],"The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes.\n\nThe study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure\u002Ftiming, connected to a speaker that delivers mother's voice.\n\nThe study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device.",[29],[704,705,706,707],"preterm","premature","NICU","neonatal","2025-09-03",{"date":590,"type":34},{"date":711,"type":34},"2024-03-08",{"date":713,"type":23},"2026-02-01",{"name":715,"class":716},"Thrive Neuromedical, LLC","INDUSTRY"]