[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585090":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":20,"studyPopulation":20,"armGroups":84,"interventions":101,"overallOfficials":20,"centralContacts":115,"locations":121,"responsibleParty":494,"collaborators":20,"id":496,"slug":497,"hasResults":498,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":498,"sex":504,"minAge":505,"maxAge":506,"enrollmentInfo":507,"targetDuration":20,"studyType":510,"phases":511,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":124,"whyStopped":20,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":528},{"fullName":5,"class":6},"Airway Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death","BPD is defined and graded based on the classification according to Jensen et al., 2019 (2019 PMID: 30995069)","Week 36 Post Menstrual Age (PMA)",[14,18,21,23,25,27,29,31,34,37,40,43,45,47,48,49,52,54,57,60,63,66,69],{"measure":15,"description":16,"timeFrame":17},"Ventilator-free days","A ventilator-free day is defined as a natural calendar day without being on invasive mechanical ventilation (ie, invasive ventilation via ETT or tracheostomy); tracheostomy will be treated as all invasive ventilation.","From birth to 36 weeks Post Menstrual Age (PMA)",{"measure":19,"description":20,"timeFrame":12},"Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD)",null,{"measure":22,"description":20,"timeFrame":12},"Incidence of death",{"measure":24,"description":11,"timeFrame":12},"Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death assessed on 3 consecutive days at week 36 PMA",{"measure":26,"description":11,"timeFrame":12},"The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD",{"measure":28,"description":11,"timeFrame":12},"The proportion of subjects with no Bronchopulmonary Dysplasia (BPD), grade 1, grade 2, or grade 3 BPD assessed on 3 consecutive days at week 36 PMA",{"measure":15,"description":16,"timeFrame":30},"From birth to day 28 of life",{"measure":32,"description":20,"timeFrame":33},"Total average days on supplemental oxygen","From birth to 36 Weeks Post Menstrual Age (PMA)",{"measure":35,"description":20,"timeFrame":36},"Total average days on continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC)","From birth to week 36 Post Menstrual Age (PMA)",{"measure":38,"description":20,"timeFrame":39},"Extubation rate","Study Day 7",{"measure":41,"description":20,"timeFrame":42},"Average preductal oxygen saturation measured by oxygen saturation to fraction of inspired oxygen ratio (SF)","From Study Days 1 to 7",{"measure":44,"description":20,"timeFrame":42},"Average preductal oxygen saturation measured by oxygen saturation index (OSI)",{"measure":10,"description":11,"timeFrame":46},"Week 40 Post Menstrual Age (PMA)",{"measure":19,"description":11,"timeFrame":46},{"measure":26,"description":11,"timeFrame":46},{"measure":50,"description":11,"timeFrame":51},"Incidence of grade 2 or grade 3 Bronchopulmonary Dysplasia (BPD) or death after excluding subjects with death at ≤ 14 days postnatal age","Week 36 and week 40 Post Menstrual Age (PMA)",{"measure":15,"description":16,"timeFrame":53},"From birth to week 40 Post Menstrual Age (PMA)",{"measure":55,"description":20,"timeFrame":56},"Survival at 6, 12 and 24 months corrected age","6, 12 and 24 month corrected age",{"measure":58,"description":20,"timeFrame":59},"Average number of hospitalizations and days in hospital","6 and 12 months corrected age",{"measure":61,"description":20,"timeFrame":62},"Incidence of chronic respiratory morbidity","12 month corrected age",{"measure":64,"description":20,"timeFrame":65},"Incidence of neurodevelopmental disability among survivors","24 months corrected age",{"measure":67,"description":20,"timeFrame":68},"Severity and frequency of treatment-emergent adverse events (TEAEs) or treatment-emergent serious adverse events (TESAEs)","From start of treatment through week 36 Post Menstrual Age (PMA) or hospital discharge, whichever comes first",{"measure":70,"description":71,"timeFrame":72},"Immunogenicity analysis","Determination of anti-SP-D antibodies in blood at day 28 of life compared to baseline), assessed in a subset of 60 patients","Day 28 of life",{"allocation":74,"interventionModel":75,"interventionModelDescription":20,"primaryPurpose":76,"observationalModel":20,"timePerspective":20,"maskingInfo":77},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":78,"maskingDescription":20,"whoMasked":79},"QUADRUPLE",[80,81,82,83],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[85,91,97],{"label":86,"type":87,"description":88,"interventionNames":89},"Zelpultide alfa 4 mg\u002Fkg plus standard of care","EXPERIMENTAL","In addition to the preterm neonate standard of care, the subjects randomized to this treatment arm will receive up to 7 administrations of zelpultide alfa at 4 mg\u002Fkg (birth weight) in 24 h intervals while the subjects are still intubated.",[90],"Drug: Zelpultide alfa",{"label":92,"type":93,"description":94,"interventionNames":95},"Placebo (air-sham) plus standard of care","SHAM_COMPARATOR","In addition to the preterm neonate standard of care, approximately 1 mL of air drawn into a dosing syringe will be administered up to 7 times to neonate subjects randomized to the control (placebo) arm, following the same means and intervals as in the treatment arm.",[96],"Other: Air-sham",{"label":98,"type":87,"description":99,"interventionNames":100},"Zelpultide alfa 6 mg\u002Fkg plus standard of care","In addition to the preterm neonate standard of care, the subjects randomized to this treatment arm will receive up to 7 administrations of zelpultide alfa at 6 mg\u002Fkg (birth weight) in 24 h intervals while the subjects are still intubated.",[90],[102,107],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":20},"OTHER","Air-sham","Room air for intratracheal administration",[92],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"DRUG","Zelpultide alfa","Reconstituted Zelpultide alfa for intratracheal administration",[86,98],[113,114],"AT-100","rhSP-D",[116],{"name":117,"role":118,"phone":119,"phoneExt":20,"email":120},"Alan Wolk","CONTACT","513-770-9630","info@airwaytherapeutics.com",[122,134,139,144,149,159,167,175,180,190,198,206,214,219,224,229,237,248,256,264,274,279,287,292,300,310,318,326,331,339,347,357,365,373,381,389,397,407,415,420,425,433,441,449,457,462,470,478,486],{"facility":123,"status":124,"city":125,"state":20,"zip":20,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":20},"Clínica y Maternidad Suizo Argentina","RECRUITING","Buenos Aires","Argentina","AR",{"type":129,"coordinates":130},"Point",[131,132],-58.37723,-34.61315,{"lat":132,"lon":131},{"facility":135,"status":124,"city":125,"state":20,"zip":20,"country":126,"countryCode":127,"cosmosGeoPoint":136,"geoPoint":138,"contacts":20},"Hospital Italiano de Buenos Aires",{"type":129,"coordinates":137},[131,132],{"lat":132,"lon":131},{"facility":140,"status":124,"city":125,"state":20,"zip":20,"country":126,"countryCode":127,"cosmosGeoPoint":141,"geoPoint":143,"contacts":20},"Hospital Sanatorio de la Trinidad San Isidro",{"type":129,"coordinates":142},[131,132],{"lat":132,"lon":131},{"facility":145,"status":124,"city":125,"state":20,"zip":20,"country":126,"countryCode":127,"cosmosGeoPoint":146,"geoPoint":148,"contacts":20},"Hospital Universitario Austral",{"type":129,"coordinates":147},[131,132],{"lat":132,"lon":131},{"facility":150,"status":124,"city":151,"state":20,"zip":20,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":158,"contacts":20},"ZAS Middelheim","Antwerp","Belgium","BE",{"type":129,"coordinates":155},[156,157],4.40026,51.22047,{"lat":157,"lon":156},{"facility":160,"status":124,"city":161,"state":20,"zip":20,"country":152,"countryCode":153,"cosmosGeoPoint":162,"geoPoint":166,"contacts":20},"UZ Leuven","Leuven",{"type":129,"coordinates":163},[164,165],4.70093,50.87959,{"lat":165,"lon":164},{"facility":168,"status":124,"city":169,"state":20,"zip":20,"country":152,"countryCode":153,"cosmosGeoPoint":170,"geoPoint":174,"contacts":20},"CHU de Liege - Hospital de la Citadelle","Liège",{"type":129,"coordinates":171},[172,173],5.56749,50.63373,{"lat":173,"lon":172},{"facility":176,"status":124,"city":169,"state":20,"zip":20,"country":152,"countryCode":153,"cosmosGeoPoint":177,"geoPoint":179,"contacts":20},"Clinique CHC MontLégia",{"type":129,"coordinates":178},[172,173],{"lat":173,"lon":172},{"facility":181,"status":124,"city":182,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":20},"CHU Lille - Hôpital Jeanne de Flandre","Lille","France","FR",{"type":129,"coordinates":186},[187,188],3.05512,50.63391,{"lat":188,"lon":187},{"facility":191,"status":124,"city":192,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":193,"geoPoint":197,"contacts":20},"CHRU Nancy","Nancy",{"type":129,"coordinates":194},[195,196],6.18496,48.68439,{"lat":196,"lon":195},{"facility":199,"status":124,"city":200,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":201,"geoPoint":205,"contacts":20},"CHU Nice","Nice",{"type":129,"coordinates":202},[203,204],7.26608,43.70313,{"lat":204,"lon":203},{"facility":207,"status":124,"city":208,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":209,"geoPoint":213,"contacts":20},"AP-HP CHU Robert-Debré - Hôpitaux de Paris","Paris",{"type":129,"coordinates":210},[211,212],2.3488,48.85341,{"lat":212,"lon":211},{"facility":215,"status":124,"city":208,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":216,"geoPoint":218,"contacts":20},"AP-HP Paris Saclay University - Hôpitaux Antoine-Béclère",{"type":129,"coordinates":217},[211,212],{"lat":212,"lon":211},{"facility":220,"status":124,"city":208,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":221,"geoPoint":223,"contacts":20},"AP-HP Paris Saclay University Bicêtre Hospital",{"type":129,"coordinates":222},[211,212],{"lat":212,"lon":211},{"facility":225,"status":124,"city":208,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":226,"geoPoint":228,"contacts":20},"AP-HP University Hospital Cochin - Port Royal",{"type":129,"coordinates":227},[211,212],{"lat":212,"lon":211},{"facility":230,"status":124,"city":231,"state":20,"zip":20,"country":183,"countryCode":184,"cosmosGeoPoint":232,"geoPoint":236,"contacts":20},"Hôpital de Poissy Saint-Germain-en-Laye","Poissy",{"type":129,"coordinates":233},[234,235],2.04952,48.92902,{"lat":235,"lon":234},{"facility":238,"status":239,"city":240,"state":20,"zip":20,"country":241,"countryCode":242,"cosmosGeoPoint":243,"geoPoint":247,"contacts":20},"Medical Faculty of TU Dresden","NOT_YET_RECRUITING","Dresden","Germany","DE",{"type":129,"coordinates":244},[245,246],13.73832,51.05089,{"lat":246,"lon":245},{"facility":249,"status":239,"city":250,"state":20,"zip":20,"country":241,"countryCode":242,"cosmosGeoPoint":251,"geoPoint":255,"contacts":20},"Universitätsklinikum Freiburg","Freiburg im Breisgau",{"type":129,"coordinates":252},[253,254],7.85222,47.9959,{"lat":254,"lon":253},{"facility":257,"status":124,"city":258,"state":20,"zip":20,"country":241,"countryCode":242,"cosmosGeoPoint":259,"geoPoint":263,"contacts":20},"University Children's Hospital Regensburg (KUNO)","Regensburg",{"type":129,"coordinates":260},[261,262],12.10161,49.01513,{"lat":262,"lon":261},{"facility":265,"status":124,"city":266,"state":20,"zip":20,"country":267,"countryCode":268,"cosmosGeoPoint":269,"geoPoint":273,"contacts":20},"Bnai Zion Medical Center","Haifa","Israel","IL",{"type":129,"coordinates":270},[271,272],34.99928,32.81303,{"lat":272,"lon":271},{"facility":275,"status":124,"city":266,"state":20,"zip":20,"country":267,"countryCode":268,"cosmosGeoPoint":276,"geoPoint":278,"contacts":20},"Rambam Medical Center",{"type":129,"coordinates":277},[271,272],{"lat":272,"lon":271},{"facility":280,"status":124,"city":281,"state":20,"zip":20,"country":267,"countryCode":268,"cosmosGeoPoint":282,"geoPoint":286,"contacts":20},"Haddasah medical center","Jerusalem",{"type":129,"coordinates":283},[284,285],35.21633,31.76904,{"lat":285,"lon":284},{"facility":288,"status":124,"city":281,"state":20,"zip":20,"country":267,"countryCode":268,"cosmosGeoPoint":289,"geoPoint":291,"contacts":20},"Shaare-Zedek Medical Center",{"type":129,"coordinates":290},[284,285],{"lat":285,"lon":284},{"facility":293,"status":124,"city":294,"state":20,"zip":20,"country":267,"countryCode":268,"cosmosGeoPoint":295,"geoPoint":299,"contacts":20},"Ziv Medical Center","Safed",{"type":129,"coordinates":296},[297,298],35.496,32.96465,{"lat":298,"lon":297},{"facility":301,"status":124,"city":302,"state":20,"zip":20,"country":303,"countryCode":304,"cosmosGeoPoint":305,"geoPoint":309,"contacts":20},"IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola","Bologna","Italy","IT",{"type":129,"coordinates":306},[307,308],11.33875,44.49381,{"lat":308,"lon":307},{"facility":311,"status":124,"city":312,"state":20,"zip":20,"country":303,"countryCode":304,"cosmosGeoPoint":313,"geoPoint":317,"contacts":20},"Istituto Giannina Gaslini","Genova",{"type":129,"coordinates":314},[315,316],11.87211,45.21604,{"lat":316,"lon":315},{"facility":319,"status":124,"city":320,"state":20,"zip":20,"country":303,"countryCode":304,"cosmosGeoPoint":321,"geoPoint":325,"contacts":20},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan",{"type":129,"coordinates":322},[323,324],12.59836,42.78235,{"lat":324,"lon":323},{"facility":327,"status":124,"city":320,"state":20,"zip":20,"country":303,"countryCode":304,"cosmosGeoPoint":328,"geoPoint":330,"contacts":20},"Ospedale dei Bambini \"V. Buzzi\"",{"type":129,"coordinates":329},[323,324],{"lat":324,"lon":323},{"facility":332,"status":124,"city":333,"state":20,"zip":20,"country":303,"countryCode":304,"cosmosGeoPoint":334,"geoPoint":338,"contacts":20},"Università degli Studi di Napoli Federico II","Naples",{"type":129,"coordinates":335},[336,337],14.26811,40.85216,{"lat":337,"lon":336},{"facility":340,"status":124,"city":341,"state":20,"zip":20,"country":303,"countryCode":304,"cosmosGeoPoint":342,"geoPoint":346,"contacts":20},"Azienda Ospedale Università di Padova","Padova",{"type":129,"coordinates":343},[344,345],11.14261,44.38225,{"lat":345,"lon":344},{"facility":348,"status":124,"city":349,"state":20,"zip":20,"country":350,"countryCode":351,"cosmosGeoPoint":352,"geoPoint":356,"contacts":20},"Uniwersyteckie Centrum Kliniczne","Gdansk","Poland","PL",{"type":129,"coordinates":353},[354,355],18.64912,54.35227,{"lat":355,"lon":354},{"facility":358,"status":124,"city":359,"state":20,"zip":20,"country":350,"countryCode":351,"cosmosGeoPoint":360,"geoPoint":364,"contacts":20},"University Hospital in Krakow","Krakow",{"type":129,"coordinates":361},[362,363],19.93658,50.06143,{"lat":363,"lon":362},{"facility":366,"status":124,"city":367,"state":20,"zip":20,"country":350,"countryCode":351,"cosmosGeoPoint":368,"geoPoint":372,"contacts":20},"Polish Mother's Memorial Hospital - Research Institute in Lodz","Lodz",{"type":129,"coordinates":369},[370,371],19.47395,51.77058,{"lat":371,"lon":370},{"facility":374,"status":124,"city":375,"state":20,"zip":20,"country":350,"countryCode":351,"cosmosGeoPoint":376,"geoPoint":380,"contacts":20},"Gynecological Obstetric Clinical Hospital of Poznan University of Medical Sciences","Poznan",{"type":129,"coordinates":377},[378,379],16.92993,52.40692,{"lat":379,"lon":378},{"facility":382,"status":124,"city":383,"state":20,"zip":20,"country":350,"countryCode":351,"cosmosGeoPoint":384,"geoPoint":388,"contacts":20},"University Clinical Hospital No. 2 PUM","Szczecin",{"type":129,"coordinates":385},[386,387],14.55302,53.42894,{"lat":387,"lon":386},{"facility":390,"status":124,"city":391,"state":20,"zip":20,"country":350,"countryCode":351,"cosmosGeoPoint":392,"geoPoint":396,"contacts":20},"University Hospital Wroclaw","Wroclaw",{"type":129,"coordinates":393},[394,395],17.03006,51.10286,{"lat":395,"lon":394},{"facility":398,"status":124,"city":399,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":402,"geoPoint":406,"contacts":20},"Hospital General Universitario de Alicante Dr. Balmis","Alicante","Spain","ES",{"type":129,"coordinates":403},[404,405],-0.48149,38.34517,{"lat":405,"lon":404},{"facility":408,"status":124,"city":409,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":410,"geoPoint":414,"contacts":20},"Hospital Clínic de Barcelona","Barcelona",{"type":129,"coordinates":411},[412,413],2.15899,41.38879,{"lat":413,"lon":412},{"facility":416,"status":124,"city":409,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":417,"geoPoint":419,"contacts":20},"Hospital de la Santa Creu i Sant Pau",{"type":129,"coordinates":418},[412,413],{"lat":413,"lon":412},{"facility":421,"status":124,"city":409,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":422,"geoPoint":424,"contacts":20},"Hospital Sant Joan de Déu",{"type":129,"coordinates":423},[412,413],{"lat":413,"lon":412},{"facility":426,"status":124,"city":427,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":428,"geoPoint":432,"contacts":20},"Hospital Universitario Cruces - OSI Ezkerraldea-Enkarterri-Cruces","Bilbao",{"type":129,"coordinates":429},[430,431],-2.92528,43.26271,{"lat":431,"lon":430},{"facility":434,"status":124,"city":435,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":436,"geoPoint":440,"contacts":20},"Hospital Universitario Puerta del Mar","Cadiz",{"type":129,"coordinates":437},[438,439],-6.2891,36.52672,{"lat":439,"lon":438},{"facility":442,"status":124,"city":443,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":444,"geoPoint":448,"contacts":20},"Hospital Universitari Arnau de Vilanova de Lleida","Lleida",{"type":129,"coordinates":445},[446,447],0.62218,41.61674,{"lat":447,"lon":446},{"facility":450,"status":124,"city":451,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":452,"geoPoint":456,"contacts":20},"Hospital General Universitario Gregorio Marañón","Madrid",{"type":129,"coordinates":453},[454,455],-3.70256,40.4165,{"lat":455,"lon":454},{"facility":458,"status":124,"city":451,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":459,"geoPoint":461,"contacts":20},"Hospital Universitario La Paz",{"type":129,"coordinates":460},[454,455],{"lat":455,"lon":454},{"facility":463,"status":124,"city":464,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":465,"geoPoint":469,"contacts":20},"Hospital Regional Universitario de Málaga","Málaga",{"type":129,"coordinates":466},[467,468],-4.42034,36.72016,{"lat":468,"lon":467},{"facility":471,"status":124,"city":472,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":473,"geoPoint":477,"contacts":20},"Hospital Clínico Universitario de Santiago","Santiago de Compostela",{"type":129,"coordinates":474},[475,476],-8.54569,42.88052,{"lat":476,"lon":475},{"facility":479,"status":124,"city":480,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":481,"geoPoint":485,"contacts":20},"Hospital Universitari i Politècnic La Fe","Valencia",{"type":129,"coordinates":482},[483,484],-0.37966,39.47391,{"lat":484,"lon":483},{"facility":487,"status":124,"city":488,"state":20,"zip":20,"country":400,"countryCode":401,"cosmosGeoPoint":489,"geoPoint":493,"contacts":20},"Hospital Universitario Miguel Servet","Zaragoza",{"type":129,"coordinates":490},[491,492],-0.87734,41.65606,{"lat":492,"lon":491},{"type":495,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100585090","phase-2-efficacy-and-safety-of-zelpultide-alfa-in-preterm-neonates-at-high-risk-of-developing-bronchopulmonary-dysplasia-bpd-100585090",false,"NCT06897839","Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)","Randomized, Double-Blind Parallel-Group, Adaptive, Three-Arm, Phase 2b\u002F3 Multicenter Study to Evaluate the Efficacy and Safety of Zelpultide Alfa in Preventing Bronchopulmonary Dysplasia (BPD) in High-Risk Preterm Neonates Compared to Standard of Care (SOC)","ZELA","Inclusion Criteria:\n\n1. Born between gestational age (GA) 22 0\u002F7 to 27 6\u002F7 weeks, inclusive.\n2. Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth.\n3. Intubated and on invasive mechanical ventilation per SOC.\n4. Able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. Subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met.\n5. Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n1. Birth weight \\\u003C 400 g or \\> 1,500 g.\n2. Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to:\n\n   * Clinically relevant Potter-like syndrome and any pulmonary congenital anomalies,\n   * Clinically relevant congenital diaphragmatic hernia,\n   * Omphalocele or gastroschisis, esophageal atresia,\n   * Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc).\n3. Active do no resuscitate (DNR) order in place.\n4. History of allergy or sensitivity to any surfactant or any component of zelpultide alfa.\n5. Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation in studies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for the mother) or up to week 36 PMA.\n6. Any condition or situation that, in the Investigator's judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate's participation in the study.","ALL","0 Minutes","96 Hours",{"count":508,"type":509},366,"ESTIMATED","INTERVENTIONAL",[512,513],"PHASE2","PHASE3","This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b\u002F3 study with an adaptive seamless design.\n\nThe goal fo this study is to determine if an investigational drug, Zelpultide Alfa, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in extremely premature babies.\n\nThe study comprises 2 parts:\n\n* Part 1: Phase 2b, dose selection and exploratory efficacy and safety.\n* Part 2: Phase 3, confirmatory efficacy and safety.\n\nIn Part 1, the study subjects will be randomized with a 1:1:1 allocation ratio to either :\n\n1. Standard of care + zelpultide alfa 4 mg\u002Fkg or,\n2. Standard of care + zelpultide alfa 6 mg\u002Fkg or,\n3. Standard of care + placebo (air-sham).\n\nIn Part 1, all three arms will be evaluated descriptively to support dose selection based on safety, tolerability, and exploratory efficacy signals. Upon completion of Part 1, the DSMC will recommend which Phase 2b dose (\"selected dose\") to progress into Part 2 to the Study Steering Committee, which will decide the dose for Part 2 (Phase 3). A sample size reassessment will be performed after Part 1 completion.\n\nIn Part 2, the selected dose of zelpultide alfa will be compared against placebo (air-sham) in a confirmatory analysis on the primary and key secondary endpoints. The study subjects will be randomized with a 1:1 allocation ratio to either:\n\n1. Standard of care + zelpultide alfa (selected dose from Part 1), or\n2. Standard of care + placebo (air-sham). The main objective in part 2 is to compare the efficacy of zelpultide alfa added to standard of care versus standard of care plus placebo (air-sham) in terms of incidence of grade 2 and grade 3 bronchopulmonary dysplasia (BPD) and death in neonates at high risk for developing BPD.\n\nIn both parts, treatment will be administered intratracheally. Participants will receive up to 7 administrations of zelpultide alfa at (4mg\u002Fkg or 6 mg\u002Fkg) or air-sham in 24 h intervals while the subjects are still intubated per standard of care.",[516],"Bronchopulmonary Dysplasia",[518,109,113],"BPD","2026-10-08",{"date":521,"type":522},"2026-10-09","ACTUAL",{"date":524,"type":522},"2025-02-03",{"date":526,"type":509},"2030-04-30",{"name":5,"class":6},49]