[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-distress-syndrome-in-premature-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-distress-syndrome-in-premature-infant":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,80,111,137,160,199,227,256,279,303,327,351],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100600740","speed-of-lung-inflation-during-ventilation-of-extremely-preterm-infants-100600740",false,"NCT07101419","Speed of Lung Inflation During Ventilation of Extremely Preterm Infants","Longer Pressure Rise Time During Mechanical Ventilation of Extremely Preterm Infants: A Randomised Crossover Trial","FLOW-VENT","Inclusion Criteria:\n\n* Admitted to participating neonatal intensive care unit\n* Born between 22+0 to 27+6 weeks' gestation\n* Current weight ≥400 grams\n* Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee \\[PC-AC+VG\\] mode on Dräger Babylog VN500\u002F800 ventilators) initiated within 72-hours post birth\n* Postnatal age ≥6 hours and ≤7 days\n* Received surfactant therapy\n* Clinically stable (as per treating and research team consensus)\n* Parent(s)\u002Flegal guardian provides prospective informed consent.\n\nExclusion Criteria:\n\n* Major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes\n* Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life\n* Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation\n* Planned for extubation from mechanical ventilation within the next 12 hours.","ALL","6 Hours","7 Days",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"NA","Babies born extremely preterm (\\\u003C28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems.\n\nThis clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment.\n\nThis study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs).\n\nThe main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?",[28,29],"Respiratory Distress Syndrome, Newborn","Respiratory Distress Syndrome in Premature Infant","NOT_YET_RECRUITING","2026-06-21",{"date":33,"type":34},"2026-06-24","ACTUAL",{"date":36,"type":22},"2027-02",{"date":38,"type":22},"2028-02",{"name":40,"class":41},"Murdoch Childrens Research Institute","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100600547","surfactant-therapy-via-supraglottic-airway-to-preterm-neonates-with-rds-in-vietnam-100600547","NCT07098910","Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam","Surfactant Therapy Via Supraglottic Airway Device Versus Endotracheal Intubation to Prevent Mechanical Ventilation in Preterm Neonates With Respiratory Distress Syndrome: An Open-label, Non-inferiority, Randomized Controlled Trial at a Level-III Neonatal Intensive Care Unit in Vietnam","NEOSURF","Inclusion Criteria:\n\n* Inborn neonate (=born in the hospital), AND\n* Gestational age \\\u003C34+0 weeks, AND\n* Birth weight ≥750g, AND\n* Age \\\u003C48 hours, AND\n* Diagnosis of RDS, confirmed with a chest x-ray or lung ultrasound, except in cases where immediate treatment is necessary and imaging would cause a delay AND\n* Indication for surfactant treatment: Infant on non-invasive support (CPAP\u002FNIPPV) and FiO2 \\>0.30 to maintain oxygen saturation (SpO2) between 90% and 95%\n\nExclusion Criteria:\n\n* Severe respiratory insufficiency in need of intubation at delivery room\n* Severe respiratory insufficiency in need of intubation and invasive mechanical ventilation after arrival to NICU\n* Previous surfactant administration\n* Previous invasive mechanical ventilation\n* Known pneumothorax\n* Major malformations\n* Physician not confident with study intervention\n* The physician decided not to include the patient due to a preference for performing INSURE\n* Excluded due to time constraints preventing completion of informed consent and trial procedures","48 Hours",{"count":53,"type":22},440,[25],"Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better. It is usually given through a procedure called INSURE, where a breathing tube is placed into the baby's trachea (via an endotracheal tube) to deliver the medicine. While effective, this method is invasive and can be uncomfortable and risky for the baby.\n\nA newer, less invasive method called SALSA uses a soft mask placed in the throat (a laryngeal mask airway) instead of an endotracheal tube to give the surfactant. This randomized controlled trial will compare SALSA to the traditional INSURE method to see if it works just as well in preventing the need for invasive breathing support within three days of treatment.\n\nThe study will include preterm babies born before 34 weeks of pregnancy and weighing at least 750 grams, at Phu San Hanoi Hospital in Vietnam. If SALSA is found to be safe and effective, it may offer a gentler, less invasive, and easier-to-perform option for treating respiratory distress syndrome in premature babies.",[29],[58,59,60,61,62,63,64,65,66,67,68],"surfactant therapy","supraglottic airway device","laryngeal mask airway","preterm infant","neonate","newborn","vietnam","SALSA","RDS","respiratory distress syndrome","very low birth weight","RECRUITING","2026-05-24",{"date":72,"type":34},"2026-05-27",{"date":74,"type":34},"2025-09-28",{"date":76,"type":22},"2029-03-30",{"name":78,"class":41},"Karolinska Institutet",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100349133","30-or-60-oxygen-at-birth-to-improve-neurodevelopmental-outcomes-in-very-low-birthweight-infants-100349133","NCT03825835","30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants","Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial","HiLo","Inclusion Criteria:\n\n* Infants born at 23 0\u002F7 weeks to 28 6\u002F7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities\n\nExclusion Criteria:\n\n* Infants who are outborn - initial resuscitation not performed at the study centre\n* Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants\n* Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes\n* Infants who will not receive full resuscitation at birth- these infants will not receive resuscitation","0 Minutes","10 Minutes",{"count":91,"type":22},1200,[25],"Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before 29 weeks' gestation. At this gestational age, the lungs are not fully developed and it is not uncommon for infants to have problems breathing at the time of birth. One complication that can arise is when an infant stops breathing and needs to be resuscitated. When preterm babies need to be resuscitated doctors must take special care because of the small infant size and the immaturity of the brain and lungs. Oxygen is used to resuscitate babies who need it, but unfortunately there is disagreement about the best oxygen concentration to use. Oxygen concentration is important because both too much and too little oxygen can cause brain injury. This research aims to fill this knowledge gap by participating in an international clinical trial to compare the effects of resuscitating babies less than 29 weeks' gestational age with either a low oxygen concentration or a high oxygen concentration. The oxygen concentrations have been selected using the best available knowledge.\n\nThis will be a cluster randomized trial where each participating hospital will be randomized to either 30 or 60 percent oxygen for the recruitment of 30 infants, and afterwards randomized to the other group for the recruitment of another 30 infants. After the trial, the investigator will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. This research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.",[95,29,96],"Premature Infant","Neurodevelopmental Outcome",[98,99,95,100],"Delivery Room","Resuscitation","Oxygen","2026-05-22",{"date":103,"type":34},"2026-05-26",{"date":105,"type":34},"2022-06-27",{"date":107,"type":22},"2029-12-30",{"name":109,"class":41},"University of Alberta",21,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":79},"100626979","utilization-of-lung-ultrasound-score-in-decision-for-minimally-invasive-surfactant-administration-100626979","NCT07442669","Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration","Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study","Inclusion Criteria:\n\n* Inborn at 27 0\u002F7 to 34 6\u002F7 weeks of gestational age\n* Spontaneously breathing at birth but requiring non-invasive respiratory support\n* RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS\n\nExclusion Criteria:\n\n* Outborn\n* Endotracheal intubation in the delivery room or within 2 hours of life\n* Surfactant in the delivery room as part of advanced resuscitation\n* Presence of major congenital malformations or chromosomal anomalies\n* Hydrops fetalis\n* Inherited disorders of metabolism\n* Air leak syndrome (pneumothorax, pneumomediastinum) prior to surfactant administration, congenital diaphragmatic hernia, congenital pneumonia, meconium aspiration syndrome\n* Infants in extremis not expected to survive","27 Weeks","34 Weeks",{"count":121,"type":22},100,[25],"This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. The research will involve 100 infants, with 67 in the prospective group and 33 serving as controls.\n\nThe primary goal is to shorten the time to treatment for these vulnerable newborns. The study will also assess whether this ultrasound-guided approach improves short-term respiratory outcomes. These secondary objectives include measuring any decrease in the need for and duration of mechanical ventilation, the length of non-invasive respiratory support, and the overall need for oxygen.\n\nThe study population includes infants born between 27 and 34 6\u002F7 weeks of gestation who are admitted to the NICU. Each participant will be monitored from birth until they are discharged or transferred. This research aligns with a growing body of evidence suggesting that lung ultrasound can be a valuable tool in neonatal care, potentially leading to earlier and more precise treatment for respiratory distress syndrome.",[28,29],[126,127,128],"Respiratory Distress","Lung ultrasound","Surfactant Administration","2026-05-20",{"date":101,"type":34},{"date":132,"type":22},"2026-07-01",{"date":134,"type":22},"2028-07-05",{"name":136,"class":41},"Hackensack Meridian Health",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":145,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100612300","optimising-breathing-support-at-extubation-in-very-preterm-infants-a-clinical-study-100612300","NCT07251790","Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study","PrePAP: Pre-Extubation Continuous Positive Airway Pressure in Very Preterm Infants: A Randomised Controlled Trial","PrePAP","Inclusion Criteria:\n\n* The infant is admitted to participating NICU\n* The infant is born between 22+0 to 29+6 weeks gestational age\n* The infant has been on a form of invasive mechanical ventilation for at least 4 hours\n* The infant is being electively extubated for the first time from invasive mechanical ventilation to nCPAP\n* The infant is clinically stable (as per clinical and research team consensus)\n* The parent(s) or legal guardian(s) provides prospective informed consent.\n\nExclusion Criteria:\n\n* The infant is born \\\u003C22 weeks or \\>30 weeks gestational age\n* The infant has a major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes\n* The infant has severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life\n* The infant is receiving invasive mechanical ventilation via nasotracheal intubation\n* The infant is planned for extubation to any other mode of non-invasive respiratory support than nCPAP, or no respiratory support\n* Refusal of informed consent from the parent(s), or the infant does not have a guardian who can provide informed consent.","0 Hours",{"count":147,"type":22},134,[25],"Many babies born very preterm (\\\u003C32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs. To reduce this damage, doctors and nurses try to change babies to gentler breathing support that does not require a breathing tube. This is usually done using a method called nasal continuous positive airway pressure (nCPAP) that uses a nosepiece to deliver breaths. This process of removing the breathing tube is called \"extubation\". Many babies will need the breathing tube put back in after extubation (for various reasons) and this is independently associated with poorer outcomes.\n\nThis research study aims to compare two ways of performing extubation - both of which are already used regularly by doctors and nurses. The \"standard extubation\" approach involves taking a baby's breathing tube out first, then applying the nosepiece and starting nCPAP. The more recent approach, called \"prePAP\", involves applying the nosepiece and starting nCPAP before taking the breathing tube out. Previous research suggests that a prePAP approach may provide better support for babies during extubation. However, larger studies are required before this approach is more commonly used.\n\nThis study is investigating whether extubating the baby with prePAP is better than extubating the baby without prePAP.\n\nThe main question it aims to answer is: Does initiating nCPAP before extubation in very preterm babies reduce the fall in their oxygen levels post-extubation?",[28,29],"2026-05-17",{"date":153,"type":34},"2026-05-19",{"date":155,"type":34},"2026-05-04",{"date":157,"type":22},"2028-03-31",{"name":40,"class":41},2,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100635248","surfactant-administration-methods-in-preterm-infants-with-rds-a-swedish-cohort-study-100635248","NCT07550218","Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study","A Prospective Observational Study of Surfactant AdministrationMethods for Preterm Infants With Respiratory Distress SyndromeWith Long-term Follow-up in the Swedish Neonatal Quality Register","Inclusion Criteria:\n\n* Patient has received surfactant by any administration method\n* Gestational age below 37 weeks'\n* First surfactant treatment given before 48 hours of age\n* Confirmed or suspected diagnosis of respiratory distress syndrome (RDS)\n\nExclusion Criteria:\n\n• Not fulfilling above inclusion criteria",{"count":168,"type":22},300,"6 Years","OBSERVATIONAL","The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS). Preterm infants often have immature lungs and a deficiency of surfactant, a substance that helps keep the lungs open and supports oxygen exchange.Surfactant can be delivered to the lungs using different techniques, including INSURE (brief intubation), LISA (via a thin catheter), SALSA (via a laryngeal mask airway), and traditional administration via endotracheal intubation followed by mechanical ventilation. The main question this study aims to answer is:Which method of surfactant administration is associated with better clinical outcomes in preterm infants with RDS?The study will prospectively collect clinical data on infants receiving surfactant as part of standard care, with long-term follow-up using data from the Swedish Neonatal Quality Register. The results are intended to be used to inform the design of a future randomized multicenter study.",[173,174,175,176,29],"Respiratory Distress Syndrome (& [Hyaline Membrane Disease])","Respiratory Distress Syndrome (Neonatal)","Respiratory Distress Syndrome (RDS)","Respiratory Distress Syndrome of Newborn",[178,179,180,181,182,183,184,185,186,65,187,66,188],"Preterm infants","Premature infants","Surfactant therapy","Supraglottic Airway","Laryngeal Mask Airway","Intubation","LISA","INSURE","Less Invasive Surfactant Therapy","Surfactant via Laryngeal or Supraglottic Airway","Respiratory Distress Syndrome","2026-04-17",{"date":191,"type":34},"2026-04-24",{"date":193,"type":22},"2026-04-27",{"date":195,"type":22},"2029-08-27",{"name":197,"class":198},"Vastra Gotaland Region","OTHER_GOV",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"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":209,"type":22},1512,[211],"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.",[29,214,215,216],"RDS of Prematurity","Surfactant Deficiency Syndrome Neonatal","Premature Birth","2026-03-23",{"date":219,"type":34},"2026-03-27",{"date":221,"type":34},"2025-01-01",{"date":223,"type":22},"2027-12-30",{"name":225,"class":41},"Indiana University",8,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":234,"sex":17,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":79},"100619445","predicting-the-need-for-prolonged-respiratory-support-in-neonates-delivered-in-a-lower-level-nicu-setting-100619445","NCT07344714","Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting","Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting","Inclusion Criteria:\n\nBoth of the following:\n\n* Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated\n* Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization.\n\nExclusion Criteria:\n\nAny one of the following:\n\n* Neonates with known or suspected congenital anomalies\n* Neonates for whom only comfort measures are planned or possible at time of delivery\n* Neonates whose parents actively declined the Minnesota Research Authorization.\n* Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.",true,"32 Weeks","41 Weeks",{"count":238,"type":22},500,"The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (\\>6 hours of life).",[28,29,241,242,243,244,245,246],"Transient Tachypnea of the Newborn","Meconium Aspiration Syndrome","Pneumonia Neonatal","Hyaline Membrane Disease","Pneumothorax","Respiratory Distress Neonatal","2026-03-16",{"date":249,"type":34},"2026-03-18",{"date":251,"type":34},"2026-03-11",{"date":253,"type":22},"2026-12-31",{"name":255,"class":41},"Mayo Clinic",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":234,"sex":17,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":79},"100565446","effect-of-implementing-evidence-based-practices-on-prevention-of-associated-nasal-pressure-injuries-among-preterm-neonates-with-non-invasive-respiratory-support-100565446","NCT06642285","Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support","Inclusion Criteria:\n\n* Preterm neonates receiving NIRS\n* whose gestational ages ranges between 30 and 37 weeks, and both genders\n\nExclusion Criteria:\n\n* all preterm neonates not receiving NIRS,\n* have prior nasal trauma caused by tracheal intubation\n* or Infants exhibiting evidence of nasal damage during the NIRS procedure,\n* have upper respiratory abnormalities.\n* preterm neonates who have undergone any type of surgery and had life-threatening congenital abnormalities.","30 Weeks","37 Weeks",{"count":265,"type":22},30,[25],"This study aims to evaluate the effect of implementing evidence based practices on prevention of associated nasal pressure injuries among preterm neonates with non invasive respiratory support",[269,29],"Mechanical Ventilation Complication","2024-10-12",{"date":272,"type":34},"2024-10-15",{"date":274,"type":34},"2024-08-01",{"date":276,"type":22},"2025-01-30",{"name":278,"class":41},"Kafrelsheikh University",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":79},"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":288,"type":22},164,[25],"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.",[292,293,294,29],"Infant, Newborn, Diseases","Prematurity","Prematurity; Extreme","2024-10-08",{"date":272,"type":34},{"date":298,"type":34},"2024-08-19",{"date":300,"type":22},"2027-02-28",{"name":302,"class":41},"University College Dublin",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":311,"maxAge":262,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100486115","the-nona-lisa-trial-100486115","NCT05609877","The NONA-LISA Trial","NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial","NONA-LISA","Inclusion Criteria:\n\n* Infants born at one of the trial sites with a gestational age of 24+0 to 29+6 weeks and meeting the criteria for first-choice surfactant treatment by LISA as described by Sweet et al.: worsening babies with RDS and FiO2 \\> 0.30 on CPAP pressure ≥6 cm H2O.\n\nExclusion Criteria:\n\n1. suspicion of lung hypoplasia,\n2. endotracheal intubation at any time before randomisation,\n3. suspicion of pneumothorax, pulmonary haemorrhage or pleural effusion before LISA,\n4. major congenital anatomical anomalies as described by the European Surveillance of Congenital Anomalies (EUROCAT).","24 Weeks",{"count":313,"type":22},324,[25],"The NONA-LISA trial will be an investigator-initiated, multicentre, pragmatic, parallel-group, blinded RCT conducted at four university hospitals across Denmark. A total of 324 inborn premature infants will be included within 36 months at four neonatal intensive care units (NICUs) across Denmark (approximately 2 infants per month per unit).\n\nThe aim is to compare LISA using a non-pharmacological approach alone with routine analgesic treatment combined with a non-pharmacological approach (according to local guidelines) regarding LISA failure defined as the need for positive pressure ventilation for 30 min or more (cumulated) within 24 hours after the procedure in infants born prior to 30 gestational weeks.",[29],"2024-09-18",{"date":319,"type":34},"2024-09-20",{"date":321,"type":34},"2024-06-01",{"date":323,"type":22},"2029-05-31",{"name":325,"class":41},"Rigshospitalet, Denmark",4,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":349,"locationsCount":79},"100538795","effect-of-nasal-cpap-versus-nippv-on-diaphragm-electrical-activity-edi-in-vlbw-preterm-infants-100538795","NCT06295484","Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants","Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive Positive Pressure Ventilation (NIPPV) On Diaphragm Electrical Activity (Edi) In Very Low Birth Weight (VLBW) Preterm Infants","Inclusion Criteria:\n\n* Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist)\n* Birth weight less than 1500 grams\n* Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen\n\nExclusion Criteria:\n\n* Congenital anomalies of the gastrointestinal tract\n* Phrenic nerve damage\n* Diaphragmatic paralysis\n* Esophageal perforation\n* Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure\n* Significant congenital heart disease (including symptomatic PDA)\n* Congenital anomalies of the diaphragm\n* Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM')\n* Ongoing treatment for sepsis\n* Ongoing treatment for necrotizing enterocolitis (NEC)\n* Ongoing treatment for lung infections\n* Narcotic analgesics\n* Gastric motility agents\n* Infants on nasal CPAP and requiring more than 35% oxygen\n* Infants with significant gastric residuals and vomiting\n* Infants with facial anomalies\n* Infants with pneumothorax or pneumomediastinum\n* Infants in the immediate postoperative period","1 Day","8 Months",{"count":337,"type":22},24,[25],"Background:\n\nIn premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.\n\nThe CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.\n\nStudies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.\n\nOne way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.",[341,342,29],"Preterm Birth","Premature Lungs","2024-03-05",{"date":345,"type":34},"2024-03-06",{"date":347,"type":34},"2021-08-21",{"date":253,"type":22},{"name":350,"class":41},"Sunnybrook Health Sciences Centre",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":17,"minAge":235,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":369,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":159},"100537672","physiologically-based-cord-clamping-to-improve-neonatal-outcomes-in-moderate-and-late-preterm-newborns-100537672","NCT06280872","Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns","Prospective Unblinded Randomized Controlled Study Assessing the Physiologically Based Cord Clamping on Ventilation Duration in Moderate and Late Preterm","PhyCordPrem","Inclusion Criteria:\n\nPregnant women followed-up in Brugmann University Hospital will be eligible to participate if:\n\n* The delivery takes place between 32 0\u002F7 and 36 6\u002F7 weeks of gestation\n* They carry singletons\n\nExclusion Criteria:\n\n* Fetal anomalies including congenital malformations, anemia, and growth restriction with abnormal Dopplers.\n* Abnormal placentation such as placenta previa.\n* Signs of fetal distress necessitating an emergency cesarean section.\n* Maternal health issue including severe anemia (defined as hemoglobin level \\\u003C 7 g\u002FdL), preeclampsia, and bleeding disorders.\n* Maternal refusal of the use of blood products.\n* General anesthesia for cesarian section.\n* Planned cord blood banking.\n* Total language barrier without possibility of translation","36 Weeks",{"count":361,"type":22},180,[25],"Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way.\n\nA baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.",[216,29,365,366,367,368],"Sepsis","Intraventricular Hemorrhage of Prematurity","Bronchodysplasia","Jaundice",[370,371,372,373],"Moderate and late preterm newborn","Neonatal respiratory morbidity","Physiological based-cord clamping","Mother-infant bonding","2024-03-01",{"date":343,"type":34},{"date":377,"type":34},"2024-02-19",{"date":379,"type":22},"2026-07",{"name":381,"class":41},"Queen Fabiola Children's University Hospital"]