[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"surfactant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:surfactant":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,96,128,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":40,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100614048","amnioinfusions-protective-effects-on-respiratory-and-longitudinal-pediatric-outcomes-after-intrapartum-thick-meconium-exposure-100614048",false,"NCT07274527","Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","The PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","PEARL","Inclusion Criteria:\n\n* Maternal age greater than or equal to 18 years old\n* Singleton pregnancy\n* Gestational age of greater than or equal to 36 weeks 0 days gestation\n* Cephalic presentation\n* Cercial dilation between 2-10 centimeters\n* Meconium\n\nExclusion Criteria:\n\n* Major fetal anomaly\n* Multiple gestation\n* Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing\n* Contraindication to internal monitors\n* Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent","ALL","18 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"NA","Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension.\n\nAlthough amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly thick.\n\nThe PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop thick meconium-stained amniotic fluid, confirmed using a simple, objective measurement (\"meconium-crit\"). Participants will be randomly assigned to receive either:\n\nWarm lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion.\n\nThe main goal is to determine whether warm LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice.\n\nBy using a clear definition of thick meconium, a warm LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Neonatal Respiratory Distress Related Conditions","Meconium","Perinatal Morbidity","Neonatal Acidosis","Cord Blood","Neonatal Brain Injury","Maternal Morbidity","Mechanical Ventilation","CPAP","Surfactant","Perinatal Death","Amnioinfusion","NICU Admission",[38,28,41,42,33,43,44,45],"Neonatal morbidity","Developmental Screening","Neonatal respiratory morbidity","Umbilical cord gas and biomarkers","Healthcare Utilization","RECRUITING","2026-05-15",{"date":49,"type":50},"2026-05-19","ACTUAL",{"date":47,"type":50},{"date":53,"type":21},"2030-04-15",{"name":55,"class":56},"Medical College of Wisconsin","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":57},"100613069","phase-4-duration-of-surfactant-administration-and-impact-on-stabilisation-of-vital-parameters-in-very-preterm-neonates-1-minutes-versus-5-minutes-100613069","NCT07261787","Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes","Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates \u003C 28 Weeks of Gestational Age","SurfStab I","Inclusion Criteria:\n\n* Preterm neonate \\\u003C28+0 weeks (gestational age up to 27 weeks and 6 days)\n* Indication of surfactant administration via the LISA method\n* Postnatal age \\\u003C 72 hours\n\nExclusion Criteria:\n\n* Invasive ventilation, indication of INSURE procedure\n* Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation\n* Preexisiting diagnose of any IVH \\> grade 2 or PVH.","0 Months","72 Hours",{"count":69,"type":21},76,[71],"PHASE4","Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation.\n\nThis randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (\\\u003C 28 weeks).",[74,75,76,36,77,78],"Neonates and Preterm Infants","Infant Respiratory Distress Syndrome","Surfactant Deficiency Syndrome Neonatal","Cerebral Oxygenation","Cerebral Oxygen Saturation",[80,81,82,83,84,85,86],"surfactant","surfactant administration","LISA","less-invasive surfactant administration","preterm neonates","cerebral oxygenation","near-infrared spectroscopy","2026-05-12",{"date":89,"type":50},"2026-05-14",{"date":91,"type":50},"2026-02-20",{"date":93,"type":21},"2028-12-01",{"name":95,"class":56},"Medical University of Graz",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":5},"100619853","phase-4-calfactant-vs-poractant-alfa-using-a-less-invasive-technique-in-preterm-infants-with-respiratory-distress-syndrome-100619853","NCT07350018","Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome","Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Born at a participating study center hospital.\n* Gestational age between 24 1\u002F7 and 29 6\u002F7 weeks (\\\u003C30 0\u002F7 weeks).\n* Postnatal age within the first 6 hours of life.\n* Being on non-invasive respiratory support.\n* Presence of clinical and radiological findings consistent with respiratory distress syndrome (RDS).\n* Indication for surfactant therapy defined as a requirement for FiO₂ \\>30% to achieve target oxygen saturation (SpO₂ 90-94%) while receiving noninvasive respiratory support with a minimum pressure of 6 cmH₂O.\n* Written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Infants who were intubated for any reason before the decision to administer surfactant.\n* Severe birth asphyxia, defined as the need for advanced resuscitation after birth, 10th minute Apgar score ≤5, and arterial blood gas within the first hour of life showing pH \\\u003C7.0 and base excess (BE) ≤-12.\n* Presence of major congenital anomalies.\n* Respiratory distress due to causes other than respiratory distress syndrome (RDS).\n* Congenital heart disease.\n* Congenital diaphragmatic hernia.\n* Pulmonary hypoplasia.\n* Chromosomal abnormalities.\n* Presence of pneumothorax.\n* Lack of informed consent.\n* Neonatal seizures presence.\n* Postnatal age greater than 6 hours.\n* Infants born outside of gestational weeks 24 1\u002F7 - 29 6\u002F7.\n* Requirement for invasive mechanical ventilation at enrollment.\n* Infants receiving noninvasive respiratory support with an FiO₂ requirement \\\u003C0.30.","0 Hours","6 Hours",{"count":106,"type":21},234,[71],"Respiratory distress syndrome (RDS) is a common cause of respiratory failure in preterm infants and is frequently treated with surfactant therapy. With the increasing use of noninvasive ventilation, less invasive methods of surfactant administration have been developed. In the technique known as Less Invasive Surfactant Administration (LISA), surfactant is delivered into the trachea through a thin catheter, without the need for endotracheal intubation. This approach may reduce lung injury and improve respiratory outcomes in spontaneously breathing preterm infants. This multicenter, prospective, randomized study aims to compare the clinical effectiveness of poractant alfa and calfactant when administered using the LISA technique in preterm infants born at less than 30 weeks' gestation with RDS who are not intubated. The study will evaluate short-term outcomes, including the need for intubation, repeat surfactant administration, and respiratory support during the first 72 hours of life, as well as longer-term outcomes such as bronchopulmonary dysplasia and other neonatal morbidities.",[110,111,36],"Respiratory Distress Syndrome in Premature Infants","Respiratory Distress Syndrome (RDS)",[113,114,115,116,117,118,82],"Respiratory Distress Syndrome","Premature infant","Poractant alfa","Calfactant","surfactant treatment","Less Invasive Surfactant Administration","2026-04-27",{"date":121,"type":50},"2026-04-28",{"date":123,"type":50},"2026-01-20",{"date":125,"type":21},"2027-02-20",{"name":127,"class":56},"Uludag University",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":103,"maxAge":67,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100595270","comparing-surfactant-administration-through-supraglottic-airway-and-thin-catheter-for-preterm-infants-100595270","NCT07030270","Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants","A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants","SALTI","Inclusion Criteria:\n\n* All preterm infants born at or greater than 29 weeks' gestational age\n* Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support and qualify for LISA procedure\n\nExclusion Criteria:\n\n* Infants who require intubation prior to surfactant therapy\n* Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies)\n* Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways",{"count":137,"type":21},40,[24],"What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube (\"Less Invasive Surfactant Administration\", called the LISA method) or through a small airway device placed in the baby's throat (\"Surfactant Administration through Laryngeal or Supraglottic Airway\", called the SALSA method). The goal is to see which method is safer and more effective for infants who are born at or after 29 weeks of pregnancy and have trouble breathing.\n\nWhat is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer breathing-related problems and fewer short-term complications than those who receive it using the LISA method.\n\nWhat are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?",[111,36],[142,143,144],"preterm infants","surfactant therapy","respiratory outcomes","NOT_YET_RECRUITING","2026-02-02",{"date":148,"type":50},"2026-02-04",{"date":150,"type":21},"2026-06-01",{"date":152,"type":21},"2029-06",{"name":154,"class":56},"University of Texas Southwestern Medical Center",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":166,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100574377","a-prospective-observational-study-of-video-laryngoscopy-versus-direct-laryngoscopy-for-insertion-of-a-thin-endotracheal-catheter-for-surfactant-administration-in-newborn-infants-100574377","NCT06758492","A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants","NEU-VODEtec","Inclusion Criteria:\n\n* newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration\n\nExclusion Criteria:\n\n* no parental consent provided to share their data","0 Minutes","28 Days",{"count":165,"type":21},600,"600 Days","OBSERVATIONAL","Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope.\n\nThe investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.",[170,111,171,36],"Respiratory Distress Syndrome (Neonatal)","Video Laryngoscopy",[173,174,80,175],"infant, newborn","respiratory distress syndrome","video laryngoscopy","2025-02-18",{"date":178,"type":50},"2025-02-20",{"date":180,"type":50},"2025-01-13",{"date":182,"type":21},"2025-12-31",{"name":184,"class":56},"University College Dublin",16]