[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603445":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":38,"overallOfficials":45,"centralContacts":60,"locations":70,"responsibleParty":295,"collaborators":23,"id":297,"slug":23,"hasResults":298,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":298,"sex":303,"minAge":23,"maxAge":304,"enrollmentInfo":305,"targetDuration":23,"studyType":308,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":73,"whyStopped":23,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":23},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Length of hospital stay","Days from birth to discharge","Month 6",{"measure":14,"description":15,"timeFrame":12},"Number of days to full oral feeds","Days from birth to full oral feeds",{"measure":17,"description":18,"timeFrame":12},"Percent of Nasogastric tube days","Proportion of days with NG",[20],{"measure":21,"description":22,"timeFrame":12},"Home Tube Feeding","Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","The current recommendation for preventing infant feeding problems is to provide cue-based feeding, which entails optimizing feeding based on infant cues, including behavioral and physiological signs of stress. These recommendations rely on appropriately recognizing infant feeding cues to inform care instead of applying time-based, volume-driven care irrespective of cues. Care providers vary widely in their subjective assessment of feeding skills, often because they lack standard education on feeding skill assessment and a \"gold standard\" tool to objectively measure infant oral feeding skill levels. This robust, step-wedge, cluster randomized trial was designed to evaluate the effect of implementing the SMART Tool in 14 different Neonatal Intensive Care Units (NICU) in the Advocate Health Midwest Region. The SMART Tool is a novel feeding assessment tool developed at Advocate Illinois Masonic Medical Center to objectively measure feeding readiness and skill. The psychometric properties were tested through a research study, and strong validity and reliability were established. The Advocate Health Midwest Region NICU standardization committee approved this tool as the sole feeding skill assessment tool to be used at each oral feed (eight times a day) for all NICU infants. Data on infants in the NICU will abstracted from the medical record at the time of discharge or death. The study will use PRISM and the REAIM Framework. The implementation framework consists of three parts that interact to influence outcomes (contextual factors, roll-out strategies, outcomes).",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"SMART Tool","EXPERIMENTAL","Feeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit.",[37],"Behavioral: SMART Tool",[39],{"type":40,"name":33,"description":41,"armGroupLabels":42,"otherNames":43},"BEHAVIORAL","The intervention in this implementation study involves (1) integrating the SMART Tool into electronic health records (EPIC), (2) educating all NICU staff (about 850 nurses, lactation consultants, speech-language pathologists, and physicians), and (3) Quality improvement to reinforce learning.",[33],[44],"feeding skill assessment",[46,50,53,56,58],{"name":47,"affiliation":48,"role":49},"Ravi Mishra, MBBS, MD","Advocate Illinois Masonic Medical Center","STUDY_CHAIR",{"name":51,"affiliation":5,"role":52},"Elizabeth Jensen, MPH, PhD","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":52},"Joseph Chase, MPH","Advocate Aurora Research Institute",{"name":57,"affiliation":48,"role":52},"Anne Albi, BS, MS",{"name":59,"affiliation":48,"role":52},"Cynthia Lira-Crame, BSN, MSN",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":23,"email":65},"Ravi Mishra, MBBS,MD,FAAP","CONTACT","804.464.7472","ravi.mishra@aah.org",{"name":67,"role":63,"phone":68,"phoneExt":23,"email":69},"Cynthia Liracrame, RN","773.296.7977","cynthia.liracrame@aah.org",[71,95,110,126,140,157,174,191,206,221,236,251,267,278],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Advocate Good Shepherd Hospital","RECRUITING","Barrington","Illinois","60010","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-88.13619,42.15391,{"lat":83,"lon":82},[86,90,93],{"name":87,"role":63,"phone":88,"phoneExt":23,"email":89},"Hope Reis, NPD","804-464-7472","hope.reis@aah.org",{"name":91,"role":92,"phone":23,"phoneExt":23,"email":23},"Jenna Felix, RN","SUB_INVESTIGATOR",{"name":94,"role":92,"phone":23,"phoneExt":23,"email":23},"Myriam Hernandez, RN",{"facility":96,"status":73,"city":97,"state":75,"zip":98,"country":77,"countryCode":78,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Advocate Trinity Hospital","Chicago","60617",{"type":80,"coordinates":100},[101,102],-87.65005,41.85003,{"lat":102,"lon":101},[105,108],{"name":106,"role":63,"phone":88,"phoneExt":23,"email":107},"Karen Beagles, RN","karen.beagles@aah.org",{"name":109,"role":92,"phone":23,"phoneExt":23,"email":23},"Amber Barnes, RN",{"facility":111,"status":73,"city":112,"state":75,"zip":113,"country":77,"countryCode":78,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Advocate Sherman Hospital","Elgin","60123",{"type":80,"coordinates":115},[116,117],-88.28119,42.03725,{"lat":117,"lon":116},[120,123,125],{"name":121,"role":63,"phone":88,"phoneExt":23,"email":122},"Cynthia Manly, RN","cynthia.manly@aah.org",{"name":124,"role":63,"phone":23,"phoneExt":23,"email":23},"Julie Vannoord",{"name":121,"role":92,"phone":23,"phoneExt":23,"email":23},{"facility":127,"status":73,"city":128,"state":75,"zip":129,"country":77,"countryCode":78,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Advocate Condell Medical Center","Libertyville","60048",{"type":80,"coordinates":131},[132,133],-87.95313,42.28308,{"lat":133,"lon":132},[136,139],{"name":137,"role":63,"phone":88,"phoneExt":23,"email":138},"Heidi Gutwoski, NPD","heidi.gutowski@aah.org",{"name":137,"role":92,"phone":23,"phoneExt":23,"email":23},{"facility":141,"status":73,"city":142,"state":75,"zip":143,"country":77,"countryCode":78,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)","Oak Lawn","60453",{"type":80,"coordinates":145},[146,147],-87.75811,41.71087,{"lat":147,"lon":146},[150,153,155],{"name":151,"role":63,"phone":88,"phoneExt":23,"email":152},"Edythe Oliver, NPD","edythe.oliver@aah.org",{"name":154,"role":92,"phone":23,"phoneExt":23,"email":23},"Katlynn Alanza, RN",{"name":156,"role":92,"phone":23,"phoneExt":23,"email":23},"Kimberly Butny, NPD",{"facility":158,"status":73,"city":159,"state":75,"zip":160,"country":77,"countryCode":78,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)","Park Ridge","60068",{"type":80,"coordinates":162},[163,164],-87.84062,42.01114,{"lat":164,"lon":163},[167,170,172],{"name":168,"role":63,"phone":88,"phoneExt":23,"email":169},"Katie Kurnick, NPD","katie.kurncik@aah.org",{"name":171,"role":92,"phone":23,"phoneExt":23,"email":23},"Angela Lake, RN",{"name":173,"role":92,"phone":23,"phoneExt":23,"email":23},"Margaret Behm, NPD",{"facility":175,"status":73,"city":176,"state":177,"zip":178,"country":77,"countryCode":78,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Aurora Medical Center Grafton","Grafton","Wisconsin","53024",{"type":80,"coordinates":180},[181,182],-87.95342,43.31973,{"lat":182,"lon":181},[185,188,189],{"name":186,"role":63,"phone":88,"phoneExt":23,"email":187},"Julie Bulgrin, NPD","julie.bulgrin@aah.org",{"name":186,"role":92,"phone":23,"phoneExt":23,"email":23},{"name":190,"role":92,"phone":23,"phoneExt":23,"email":23},"Amy Gundrum, RN",{"facility":192,"status":73,"city":193,"state":177,"zip":194,"country":77,"countryCode":78,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Aurora BayCare Medical Center","Green Bay","54311",{"type":80,"coordinates":196},[197,198],-88.01983,44.51916,{"lat":198,"lon":197},[201,204],{"name":202,"role":63,"phone":88,"phoneExt":23,"email":203},"Erica Huettl, NPD","erica.huettl@aah.org",{"name":205,"role":92,"phone":23,"phoneExt":23,"email":23},"Halli Schneiderwendt, RN",{"facility":207,"status":73,"city":208,"state":177,"zip":209,"country":77,"countryCode":78,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Aurora Medical Center Kenosha","Kenosha","53142",{"type":80,"coordinates":211},[212,213],-87.82119,42.58474,{"lat":213,"lon":212},[216,219],{"name":217,"role":63,"phone":88,"phoneExt":23,"email":218},"Margaret Loehrke, NPD","margaret.loehrke@aah.org",{"name":220,"role":92,"phone":23,"phoneExt":23,"email":23},"Samantha Goodenough, RN",{"facility":222,"status":73,"city":223,"state":177,"zip":224,"country":77,"countryCode":78,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Aurora Sinai Medical Center","Milwaukee","53233",{"type":80,"coordinates":226},[227,228],-87.90647,43.0389,{"lat":228,"lon":227},[231,234],{"name":232,"role":63,"phone":88,"phoneExt":23,"email":233},"Kate Scythe, NPD","katelyn.scythe@aah.org",{"name":235,"role":92,"phone":23,"phoneExt":23,"email":23},"Shannon Brandel, SLP",{"facility":237,"status":73,"city":238,"state":177,"zip":239,"country":77,"countryCode":78,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Aurora Medical Center Oshkosh","Oshkosh","54904",{"type":80,"coordinates":241},[242,243],-88.54261,44.02471,{"lat":243,"lon":242},[246,249],{"name":247,"role":63,"phone":88,"phoneExt":23,"email":248},"Abbey Schonscheck, RN","abbey.schonscheck@aah.org",{"name":250,"role":92,"phone":23,"phoneExt":23,"email":23},"Wendy Roesler, RN",{"facility":252,"status":73,"city":253,"state":177,"zip":254,"country":77,"countryCode":78,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Aurora Medical Center - Sheboygan County","Sheboygan","53081",{"type":80,"coordinates":256},[257,258],-87.71453,43.75083,{"lat":258,"lon":257},[261,264,266],{"name":262,"role":63,"phone":88,"phoneExt":23,"email":263},"Michaele Schramm, RN","michaele.schramm@aah.org",{"name":265,"role":63,"phone":23,"phoneExt":23,"email":23},"Sara Jeanty, NPD",{"name":262,"role":92,"phone":23,"phoneExt":23,"email":23},{"facility":268,"status":73,"city":269,"state":177,"zip":270,"country":77,"countryCode":78,"cosmosGeoPoint":23,"geoPoint":23,"contacts":271},"Aurora Medical Center - Summit","Summit","53066",[272,275,276],{"name":273,"role":63,"phone":88,"phoneExt":23,"email":274},"Dawn Hron, NPD","dawn.hron@aah.org",{"name":273,"role":92,"phone":23,"phoneExt":23,"email":23},{"name":277,"role":92,"phone":23,"phoneExt":23,"email":23},"Brenda Hahn, RN",{"facility":279,"status":73,"city":280,"state":177,"zip":281,"country":77,"countryCode":78,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"Aurora West Allis Medical Center","West Allis","53227",{"type":80,"coordinates":283},[284,285],-88.00703,43.01668,{"lat":285,"lon":284},[288,291,293],{"name":289,"role":63,"phone":88,"phoneExt":23,"email":290},"Shannon Schubel, NPD","shannon.schubel@aah.org",{"name":292,"role":92,"phone":23,"phoneExt":23,"email":23},"Carlye Butler, RN",{"name":294,"role":92,"phone":23,"phoneExt":23,"email":23},"Jennifer Kurziak, RN",{"type":296,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100603445",false,"NCT07136610","Standardized Application of Feeding Evaluations Using SMART Tool","SAFEST","Inclusion Criteria:\n\n* Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU\n\nExclusion Criteria:\n\n* No oral feeding started by July 15, 2026","ALL","1 Year",{"count":306,"type":307},3500,"ESTIMATED","INTERVENTIONAL",[25],"Premature and medically complex infants have delayed development of oral feeding skills, leading to prolonged hospitalization, costs, and family stress. There is no \"gold standard\" infant feeding skill assessment tool for bedside clinicians. The research team developed a novel feeding skill assessment, the SMART Tool, to monitor infant feeding skill development in the neonatal intensive care unit. This study aims to determine whether this tool improves clinical outcomes, including reduced hospital days and enhanced safety and quality of infant feedings.",[312],"Infant and Young Child Feeding",[314,315,316,317,318,319,320,321,322,323],"premature infants","medically complex infants","infant feeding","feeding skills assessment","length of stay","infant developmental assessment","dysphagia of newborn","cluster randomized trial","length of NICU stay","breastfeeding","2025-08-27",{"date":326,"type":327},"2025-08-28","ACTUAL",{"date":329,"type":327},"2025-08-01",{"date":331,"type":307},"2026-07",{"name":5,"class":6},14]