[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-lungs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-lungs":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100596778","baby-abs-abdominal-binder-study-100596778",false,"NCT07049900","Baby ABS (Abdominal Binder Study)","Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support","Inclusion Criteria:\n\n* Premature viable neonates with corrected gestational age of 26-31 weeks\n* Anticipated to require non-invasive continuous positive pressure ventilation including bCPAP, CPAP, and NAVA CPAP for a minimum of 2 weeks either on their first trial of CPAP or after extubation.\n\nExclusion Criteria:\n\n* Outside of gestational age at birth\n* Umbilical lines\n* Genetic condition or neuromuscular anomaly\n* Known abdominal anomaly\n* Non-viable neonates and neonates with uncertain viability who are not anticipated to be able to survive with standard NICU care.\n* Surgical intervention on the abdominal wall, such as gastroschisis or history of surgical NEC\n* Compromised skin integrity of abdominal wall\n* Any condition in the opinion of the investigator that would risk the data integrity or collection of the study","ALL","26 Weeks","31 Weeks",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.",[27,28,29,30],"Premature","Premature Lungs","Ventilator Lung; Newborn","Rectus Abdominis",[32,33,34],"bCPAP","CPAP","NAVA CPAP","RECRUITING","2025-09-22",{"date":38,"type":39},"2025-09-26","ACTUAL",{"date":36,"type":39},{"date":42,"type":21},"2027-02-28",{"name":44,"class":45},"University of Minnesota","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":46},"100533361","clinical-trial-for-the-evaluation-of-customized-3d-printed-niv-nasal-masks-in-premature-infants-100533361","NCT06224816","Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants","Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants","M3DPREMAT","Inclusion Criteria:\n\n* Newborn prematurity\n* Age: less than 30 days of life\n* Required respiratory support with non-invasive ventilation (NIV)\n* Premature infant has not been on NIV for more than 3 days before being included in the trial.\n* Signature of the Informed Consent (IC)\n\nExclusion Criteria:\n\n* Failure to meet entry criteria\n* Cyanotic congenital heart disease diagnosis\n* Presence of serious malformations\n* Presence of airway malformations","0 Days","30 Days",{"count":58,"type":21},60,[24],"Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).\n\nPremature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.\n\nTo compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm \\\u003C 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and\u002For sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.",[28],[63,64,65,66,67,27,68,69,70,71,72,73,74,75],"Neonatology","Nasal mask","3D printing","Additive manufacturing","Newborn","Prematurity","Neonate","Non-Invasive Ventilation (NIV)","Oxygen saturation","SolidWorks","3D scanner","Customized device","Continuous positive airway pressure (CPAP)","2024-04-16",{"date":78,"type":39},"2024-04-18",{"date":76,"type":39},{"date":81,"type":21},"2026-12",{"name":83,"class":45},"Hospital Universitario 12 de Octubre",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":46},"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":94,"type":21},24,[24],"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.",[98,28,99],"Preterm Birth","Respiratory Distress Syndrome in Premature Infant","2024-03-05",{"date":102,"type":39},"2024-03-06",{"date":104,"type":39},"2021-08-21",{"date":106,"type":21},"2026-12-31",{"name":108,"class":45},"Sunnybrook Health Sciences Centre"]