[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07417111":3,"trial-entities:NCT07417111":291,"trial-summary:NCT07417111":295},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":73,"minimum_age":17,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":95,"locations":97,"central_contacts":278,"overall_officials":287,"references":289,"see_also_links":290},"NCT07417111","NICHD-NRN-0067","Continued Pressure for Alveolar Protection (CPAP Trial)","Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)","RECRUITING","2029-01-30","2026-07","2026-07-14","2026-11-05","NICHD Neonatal Research Network","NETWORK",true,"The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.",null,[19],"Bronchopulmonary Dysplasia (BPD)",[21,22],"Continuous Positive Airway Pressure","CPAP","INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},860,"ESTIMATED",[31,35],{"type":32,"name":22,"description":33,"armGroupLabels":34},"DEVICE","Prior to study entry, the CPAP interface (includes RAM cannula, Optiflow, large bore cannulas, mask, prongs) and mode (bubble, variable-flow, ventilator-derived) used is at the discretion of the provider and center. After study entry, CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.",[21],{"type":32,"name":36,"description":37,"armGroupLabels":38},"Nasal Cannula","HFNC at 4 L\u002Fmin will be used initially in the control group. Flow should be titrated down by 1 L\u002Fmin per day until ≤0.5 L\u002Fkg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L\u002Fmin maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Bronchopulmonary Dysplasia or Death","The likelihood of BPD or death at 36 weeks' Postmenstrual Age (PMA): a five-level ordinal outcome (death, survival with grade 3 BPD, survival with grade 2 BPD, survival with grade 1 BPD, and survival free of any BPD).","36 Weeks' PMA",[45,49,52,55,58,62,66,69],{"measure":46,"description":47,"timeFrame":48},"Days alive and off respiratory support","The number of days alive and off respiratory support from 34 weeks' to 40 weeks' PMA","34-40 weeks' PMA",{"measure":50,"description":51,"timeFrame":43},"Mortality at 36 Weeks","Mortality",{"measure":53,"description":54,"timeFrame":43},"Death or Grade 2-3 BPD","Mortality at 36 weeks' PMA or grade 3 BPD",{"measure":56,"description":57,"timeFrame":43},"Death or Grade 3 BPD","Mortality or grade 3 BPD",{"measure":59,"description":60,"timeFrame":61},"Retinopathy of prematurity","Retinopathy of prematurity ≥ stage 3 or requiring treatment (laser\u002Fanti-VEGF)","52 weeks' PMA",{"measure":63,"description":64,"timeFrame":65},"Respiratory support, supplemental oxygen, and pulmonary medications","Use of supplemental oxygen, respiratory support (including low-flow nasal cannula), and pulmonary medications (methylxanthines, steroids, diuretics, albuterol) at discharge and 40 weeks' PMA","40 weeks' PMA",{"measure":67,"description":68,"timeFrame":61},"Full PO feedings","PMA at first full PO feeding (where full PO feeding is defined as intake of 120 mL\u002Fkg\u002Fday by mouth, even if an NG tube remains in situ)",{"measure":70,"description":71,"timeFrame":72},"Length of hospitalization","Length of hospitalization from 34 weeks' PMA","52 Weeks' PMA","ALL","31 Weeks",false,{"inclusion":77,"exclusion":86,"raw_text":94},[78,79,80,81,82,83,84,85],"Gestational age \\\u003C29 weeks at birth","PMA \\\u003C32 weeks at study entry","On treatment with CPAP without a rate in FiO2 \\\u003C0.25 and PEEP of 4-5 cmH2O","Meet stability criteria:","If previously intubated must be extubated ≥ 72 hours","\\\u003C3 self-resolving apneas (≤ 20 s) and\u002For bradycardia (\\\u003C100 bpm) in any hour over previous 6 hours","No episodes of apnea or bradycardia requiring intervention (oxygen\u002Fstimulation\u002Fbag and mask) for 24 hours","Parents\u002Flegal guardians consent for enrollment",[87,88,89,90,91,92,93],"Major malformation","Neuromuscular condition that affects respiration","Terminal illness","Decision to withhold or limit support","Too sick to participate in opinion of Attending physician","Clinical shock, sepsis","Planned surgery during study period","Inclusion Criteria:\n\n* Gestational age \\\u003C29 weeks at birth\n* PMA \\\u003C32 weeks at study entry\n* On treatment with CPAP without a rate in FiO2 \\\u003C0.25 and PEEP of 4-5 cmH2O\n* Meet stability criteria:\n* If previously intubated must be extubated ≥ 72 hours\n* \\\u003C3 self-resolving apneas (≤ 20 s) and\u002For bradycardia (\\\u003C100 bpm) in any hour over previous 6 hours\n* No episodes of apnea or bradycardia requiring intervention (oxygen\u002Fstimulation\u002Fbag and mask) for 24 hours\n* Parents\u002Flegal guardians consent for enrollment\n\nExclusion Criteria:\n\n* Major malformation\n* Neuromuscular condition that affects respiration\n* Terminal illness\n* Decision to withhold or limit support\n* Too sick to participate in opinion of Attending physician\n* Clinical shock, sepsis\n* Planned surgery during study period",[96],"CHILD",[98,113,125,136,148,160,172,184,196,208,220,231,243,255,266],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":110},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",[105,108],{"name":106,"role":107},"Waldemar A Carlo, MD","CONTACT",{"name":106,"role":109},"PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},33.52066,-86.80249,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":103,"contacts":118,"geoPoint":122},"Stanford University","Palo Alto","California","94304",[119,121],{"name":120,"role":107},"Valerie Chock, MD",{"name":120,"role":109},{"lat":123,"lon":124},37.44188,-122.14302,{"facility":126,"status":8,"city":127,"state":116,"zip":128,"country":103,"contacts":129,"geoPoint":133},"Sharp Mary Birch Hospital for Women & Newborns","San Diego","92123",[130,132],{"name":131,"role":107},"Anup Katheria, MD",{"name":131,"role":109},{"lat":134,"lon":135},32.71571,-117.16472,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":103,"contacts":141,"geoPoint":145},"Emory University","Atlanta","Georgia","30303",[142,144],{"name":143,"role":107},"Ravi Patel, MD",{"name":143,"role":109},{"lat":146,"lon":147},33.749,-84.38798,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":103,"contacts":153,"geoPoint":157},"Northwestern Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",[154,156],{"name":155,"role":107},"Aaron Hamvas, MD",{"name":155,"role":109},{"lat":158,"lon":159},41.85003,-87.65005,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":103,"contacts":165,"geoPoint":169},"University of Iowa","Iowa City","Iowa","52242",[166,168],{"name":167,"role":107},"Tarah Colaizy, MD",{"name":167,"role":109},{"lat":170,"lon":171},41.66113,-91.53017,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":103,"contacts":177,"geoPoint":181},"University of Mississippi Medical Center - Children's of Mississippi","Jackson","Mississippi","39216",[178,180],{"name":179,"role":107},"Abhay Bhatt, MD",{"name":179,"role":109},{"lat":182,"lon":183},32.29876,-90.18481,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":103,"contacts":189,"geoPoint":193},"University of New Mexico","Albuquerque","New Mexico","87131",[190,192],{"name":191,"role":107},"Janell Fuller, MD",{"name":191,"role":109},{"lat":194,"lon":195},35.08449,-106.65114,{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":103,"contacts":201,"geoPoint":205},"Duke University","Durham","North Carolina","27710",[202,204],{"name":203,"role":107},"Michael Cotton, MD",{"name":203,"role":109},{"lat":206,"lon":207},35.99403,-78.89862,{"facility":209,"status":8,"city":210,"state":211,"zip":212,"country":103,"contacts":213,"geoPoint":217},"Cincinnati Children's Medical Center","Cincinnati","Ohio","45267",[214,216],{"name":215,"role":107},"Stephanie Merhar, MD MS",{"name":215,"role":109},{"lat":218,"lon":219},39.12711,-84.51439,{"facility":221,"status":8,"city":222,"state":211,"zip":223,"country":103,"contacts":224,"geoPoint":228},"Case Western Reserve University, Rainbow Babies and Children's Hospital","Cleveland","44106",[225,227],{"name":226,"role":107},"Anna M Hibbs, MD",{"name":226,"role":109},{"lat":229,"lon":230},41.4995,-81.69541,{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":103,"contacts":236,"geoPoint":240},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[237,239],{"name":238,"role":107},"Sara DeMauro, MD",{"name":238,"role":109},{"lat":241,"lon":242},39.95238,-75.16362,{"facility":244,"status":8,"city":245,"state":246,"zip":247,"country":103,"contacts":248,"geoPoint":252},"University of Texas Southwestern Medical Center at Dallas","Dallas","Texas","75235",[249,251],{"name":250,"role":107},"Myra Wyckoff, MD",{"name":250,"role":109},{"lat":253,"lon":254},32.78306,-96.80667,{"facility":256,"status":8,"city":257,"state":246,"zip":258,"country":103,"contacts":259,"geoPoint":263},"University of Texas Health Science Center at Houston","Houston","77030",[260,262],{"name":261,"role":107},"Matthew Rysavy, MD",{"name":261,"role":109},{"lat":264,"lon":265},29.76328,-95.36327,{"facility":267,"status":8,"city":268,"state":269,"zip":270,"country":103,"contacts":271,"geoPoint":275},"University of Utah","Salt Lake City","Utah","84108",[272,274],{"name":273,"role":107},"Robin Ohls, MD",{"name":273,"role":109},{"lat":276,"lon":277},40.76078,-111.89105,[279,283],{"name":280,"role":107,"phone":281,"email":282},"Colm P. Travers, MD","205-934-3100","cptravers@uabmc.edu",{"name":284,"role":107,"phone":285,"email":286},"Abhik Das, PhD","301-230-4640","adas@rti.org",[288],{"name":280,"affiliation":99,"role":109},[],[],{"nct_id":4,"conditions":292,"biomarkers":294},[293],"Bronchopulmonary Dysplasia",[],{"nct_id":4,"found":15,"summary":296,"prompt_version":306},{"design":297,"status":298,"heading":299,"summary":300,"follow_up":301,"word_count":302,"commitments":303,"compensation":304,"drugs_mentioned":305},"This is an interventional study comparing two different breathing support strategies. It plans to enroll 860 participants.","completed","CPAP Trial for Bronchopulmonary Dysplasia (BPD)","This study, called the CPAP Trial, is looking at whether continuing a breathing support called CPAP (Continuous Positive Airway Pressure) for a longer time can help prevent a lung condition called Bronchopulmonary Dysplasia (BPD) or death in premature babies. Researchers want to see if extending CPAP until 34 weeks after conception, or for at least two extra weeks, is better than gradually switching to a nasal cannula (a small tube that delivers oxygen). This study is for babies born before 29 weeks of pregnancy who are currently on CPAP and meet certain stability requirements. The main goal is to see if there's a difference in BPD or death by 36 weeks after conception. The study aims to enroll 860 babies.","Participants will be followed until 36 weeks' postmenstrual age (PMA) to assess for bronchopulmonary dysplasia or death.",120,"Not specified in the trial record.","Not stated in the trial record.",[22,36],"v2"]