[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600757":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":114,"collaborators":116,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":30,"studyType":142,"phases":143,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Montelukast Sodium","EXPERIMENTAL","Once daily montelukast dosed at 0.75 mg\u002Fkg\u002Fday, maximum dose 4mg. 4mg of montelukast mixed in 5mlL breast milk\u002Fformula for a concentration of 0.8mg\u002FmL.",[13],"Drug: montelukast 4 mg granule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Plain breast milk or formula",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","montelukast 4 mg granule","Montelukast sodium (4 mg oral granules) dissolved into 5mL of breast milk\u002Fformula yielding a solution concentration of 0.8mg\u002FmL. Dosed once daily by weight, montelukast (0.75 mg\u002Fkg\u002Fday) or placebo .",[9],[27],"montelukast sodium",{"type":22,"name":15,"description":17,"armGroupLabels":29,"otherNames":30},[15],null,[32,52,70,85,100],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Arkansas Children's Hospital","RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-92.28959,34.74648,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":30,"email":51},"Ankita Shukla, MD","CONTACT","501-364-1100","DaniellA@archildrens.org",{"facility":53,"status":34,"city":54,"state":55,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of Massachusetts","Amherst","Massachusetts","01003",{"type":41,"coordinates":58},[59,60],-72.51852,42.36723,{"lat":60,"lon":59},[63,67],{"name":64,"role":49,"phone":65,"phoneExt":30,"email":66},"Madeline French, MBE","508-334-6180","Madeline.French2@umassmed.edu",{"name":68,"role":69,"phone":30,"phoneExt":30,"email":30},"Lawrence Rhein, MD","PRINCIPAL_INVESTIGATOR",{"facility":71,"status":34,"city":72,"state":73,"zip":74,"country":38,"countryCode":39,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Medical Center of Southern Nevada","Las Vegas","Nevada","89102",{"type":41,"coordinates":76},[77,78],-115.13722,36.17497,{"lat":78,"lon":77},[81],{"name":82,"role":49,"phone":83,"phoneExt":30,"email":84},"Francis Banfro, MD","323-376-2369","robert.bimbi@umcsn.com",{"facility":86,"status":34,"city":87,"state":88,"zip":89,"country":38,"countryCode":39,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of North Carolina (UNC)","Chapel Hill","North Carolina","27599",{"type":41,"coordinates":91},[92,93],-79.05584,35.9132,{"lat":93,"lon":92},[96],{"name":97,"role":49,"phone":98,"phoneExt":30,"email":99},"Wesley Jackson, MD","984-215-3449","Traci_Clark@med.unc.edu",{"facility":101,"status":34,"city":102,"state":88,"zip":103,"country":38,"countryCode":39,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"East Carolina University","Greenville","27858",{"type":41,"coordinates":105},[106,107],-77.36635,35.61266,{"lat":107,"lon":106},[110],{"name":111,"role":49,"phone":112,"phoneExt":30,"email":113},"Ryan Moore, MD","252-814-8415","moseleysh@ecu.edu",{"type":115,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[117,120,122,123,124,126],{"name":118,"class":119},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":121,"class":6},"University of North Carolina, Chapel Hill",{"name":71,"class":6},{"name":101,"class":6},{"name":125,"class":6},"University of Massachusetts, Worcester",{"name":127,"class":6},"Arkansas Children's Hospital Research Institute","100600757","phase-1-pk-safety-and-preliminary-efficacy-study-of-montelukast-in-critically-ill-infants-with-developing-bronchopulmonary-dysplasia-100600757",false,"NCT07101640","PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia","Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia","PRISM","Inclusion Criteria\n\n1. Documented informed consent from parent or guardian, prior to study activities\n2. Receiving mechanical ventilation \\[high frequency or conventional\\] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization\n3. \\\u003C28 weeks' gestational age and \\\u003C1000 g bodyweight at birth\n4. 7 to 28 (inclusive) days postnatal age at the time of first study drug dose\n5. Able to tolerate 5 mL of enteral volume\n\nExclusion Criteria\n\n1. Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)\n2. Previous exposure to montelukast within 7 days prior to randomization\n3. Known allergy to montelukast\n4. PI deems infant - prior to enrollment - is not expected to survive\n5. Has a disease complication that would preclude safe participation of the participant\n6. Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study until after resolution of the acute event\n7. Congenital lung and diaphragmatic malformations","ALL","7 Days","28 Days",{"count":140,"type":141},28,"ESTIMATED","INTERVENTIONAL",[144,145],"PHASE1","PHASE2","The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream.\n\nData supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg\u002Fkg\u002Fday, which aligns with the proposed initial dose of 0.75 mg\u002Fkg\u002Fday. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are \"developing BPD.\" Thus, researchers expect clinical benefit for preterm infants in this study.\n\nDespite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants.",[148,149,150],"Bronchopulmonary Dysplasia (BPD)","Premature Births","Critical Illness",[152,153,154,155],"PK","Pharmacokinetics","bronchopulmonary dysplasia","montelukast","2026-06-01",{"date":158,"type":159},"2026-06-02","ACTUAL",{"date":161,"type":159},"2026-02-23",{"date":163,"type":141},"2028-06-30",{"name":5,"class":6},5]