Standardized Application of Feeding Evaluations Using SMART Tool
NCT ID: NCT07136610
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3500 participants
INTERVENTIONAL
2025-08-01
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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SMART Tool
Feeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit.
SMART Tool
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.
Interventions
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SMART Tool
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Ravi Mishra, MBBS, MD
Role: STUDY_CHAIR
Advocate Illinois Masonic Medical Center
Elizabeth Jensen, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Joseph Chase, MPH
Role: PRINCIPAL_INVESTIGATOR
Advocate Aurora Research Institute
Anne Albi, BS, MS
Role: PRINCIPAL_INVESTIGATOR
Advocate Illinois Masonic Medical Center
Cynthia Lira-Crame, BSN, MSN
Role: PRINCIPAL_INVESTIGATOR
Advocate Illinois Masonic Medical Center
Locations
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Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Advocate Trinity Hospital
Chicago, Illinois, United States
Advocate Sherman Hospital
Elgin, Illinois, United States
Advocate Condell Medical Center
Libertyville, Illinois, United States
Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)
Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)
Park Ridge, Illinois, United States
Aurora Medical Center Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Medical Center Kenosha
Kenosha, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Aurora Medical Center Oshkosh
Oshkosh, Wisconsin, United States
Aurora Medical Center - Sheboygan County
Sheboygan, Wisconsin, United States
Aurora Medical Center - Summit
Summit, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Julie Vannoord
Role: backup
Sara Jeanty, NPD
Role: backup
References
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Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
Hemming K, Taljaard M. Key considerations for designing, conducting and analysing a cluster randomized trial. Int J Epidemiol. 2023 Oct 5;52(5):1648-1658. doi: 10.1093/ije/dyad064.
Glasgow RE, Trinkley KE, Ford B, Rabin BA. The Application and Evolution of the Practical, Robust Implementation and Sustainability Model (PRISM): History and Innovations. Glob Implement Res Appl. 2024;4(4):404-420. doi: 10.1007/s43477-024-00134-6. Epub 2024 Aug 31.
Browne JV, Jaeger CB, Kenner C; Gravens Consensus Committee on Infant and Family Centered Developmental Care. Executive summary: standards, competencies, and recommended best practices for infant- and family-centered developmental care in the intensive care unit. J Perinatol. 2020 Sep;40(Suppl 1):5-10. doi: 10.1038/s41372-020-0767-1.
Russ SA, Hotez E, Berghaus M, Verbiest S, Hoover C, Schor EL, Halfon N. What Makes an Intervention a Life Course Intervention? Pediatrics. 2022 May 1;149(Suppl 5):e2021053509D. doi: 10.1542/peds.2021-053509D.
Sanders MR, Hall SL. Trauma-informed care in the newborn intensive care unit: promoting safety, security and connectedness. J Perinatol. 2018 Jan;38(1):3-10. doi: 10.1038/jp.2017.124. Epub 2017 Aug 17.
Samane S, Yadollah ZP, Marzieh H, Karimollah HT, Reza ZM, Afsaneh A, Als H. Cue-based feeding and short-term health outcomes of premature infants in newborn intensive care units: a non-randomized trial. BMC Pediatr. 2022 Jan 6;22(1):23. doi: 10.1186/s12887-021-03077-1.
Pineda R, Harris R, Foci F, Roussin J, Wallendorf M. Neonatal Eating Outcome Assessment: tool development and inter-rater reliability. Acta Paediatr. 2018 Mar;107(3):414-424. doi: 10.1111/apa.14128. Epub 2017 Dec 8.
Thoyre SM, Shaker CS, Pridham KF. The early feeding skills assessment for preterm infants. Neonatal Netw. 2005 May-Jun;24(3):7-16. doi: 10.1891/0730-0832.24.3.7.
Lubbe W. Clinicians guide for cue-based transition to oral feeding in preterm infants: An easy-to-use clinical guide. J Eval Clin Pract. 2018 Feb;24(1):80-88. doi: 10.1111/jep.12721. Epub 2017 Mar 2.
Crapnell TL, Rogers CE, Neil JJ, Inder TE, Woodward LJ, Pineda RG. Factors associated with feeding difficulties in the very preterm infant. Acta Paediatr. 2013 Dec;102(12):e539-45. doi: 10.1111/apa.12393. Epub 2013 Sep 30.
Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.
Goday PS, Huh SY, Silverman A, Lukens CT, Dodrill P, Cohen SS, Delaney AL, Feuling MB, Noel RJ, Gisel E, Kenzer A, Kessler DB, Kraus de Camargo O, Browne J, Phalen JA. Pediatric Feeding Disorder: Consensus Definition and Conceptual Framework. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):124-129. doi: 10.1097/MPG.0000000000002188.
Alshaikh B, Yusuf K, Dressler-Mund D, Mehrem AA, Augustine S, Bodani J, Yoon E, Shah P; Canadian Neonatal Network (CNN) and Canadian Preterm Birth Network (CPTBN) Investigators. Rates and Determinants of Home Nasogastric Tube Feeding in Infants Born Very Preterm. J Pediatr. 2022 Jul;246:26-33.e2. doi: 10.1016/j.jpeds.2022.03.012. Epub 2022 Mar 14.
Macias R, Peterson D, Korkis L, Edson R, Gall R. Prevalence and Impact of Feeding-Related Events on Hospital Stay in Preterm and Term Newborns. Adv Neonatal Care. 2023 Dec 1;23(6):541-546. doi: 10.1097/ANC.0000000000001115. Epub 2023 Oct 19.
Hannan KE, Hwang SS, Bourque SL. Readmissions among NICU graduates: Who, when and why? Semin Perinatol. 2020 Jun;44(4):151245. doi: 10.1016/j.semperi.2020.151245. Epub 2020 Mar 13.
Edwards L, Cotten CM, Smith PB, Goldberg R, Saha S, Das A, Laptook AR, Stoll BJ, Bell EF, Carlo WA, D'Angio CT, DeMauro SB, Sanchez PJ, Shankaran S, Van Meurs KP, Vohr BR, Walsh MC, Malcolm WF; Eunice Kennedy Shriver National Institute of Child Health and Human Development. Inadequate oral feeding as a barrier to discharge in moderately preterm infants. J Perinatol. 2019 Sep;39(9):1219-1228. doi: 10.1038/s41372-019-0422-x. Epub 2019 Jul 11.
Related Links
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Psychometric Properties of the SMART Feeding Tool
Psychometric Properties of SMART Feeding Tool - AHMW SHARE
Other Identifiers
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IRB00132685
Identifier Type: -
Identifier Source: org_study_id
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