Standardized Application of Feeding Evaluations Using SMART Tool
SAFEST
1 other identifier
interventional
3,500
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 15, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
August 28, 2025
August 1, 2025
11 months
August 15, 2025
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Length of hospital stay
Days from birth to discharge
Month 6
Number of days to full oral feeds
Days from birth to full oral feeds
Month 6
Percent of Nasogastric tube days
Proportion of days with NG
Month 6
Secondary Outcomes (1)
Home Tube Feeding
Month 6
Study Arms (1)
SMART Tool
EXPERIMENTALFeeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU
You may not qualify if:
- No oral feeding started by July 15, 2026
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Advocate Trinity Hospital
Chicago, Illinois, 60617, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Advocate Condell Medical Center
Libertyville, Illinois, 60048, United States
Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)
Oak Lawn, Illinois, 60453, United States
Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)
Park Ridge, Illinois, 60068, United States
Aurora Medical Center Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Medical Center Kenosha
Kenosha, Wisconsin, 53142, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Aurora Medical Center Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Medical Center - Sheboygan County
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center - Summit
Summit, Wisconsin, 53066, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Related Publications (17)
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PMID: 16829207BACKGROUNDHemming 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.
PMID: 37203433BACKGROUNDGlasgow 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.
PMID: 39568619BACKGROUNDBrowne 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.
PMID: 32859958BACKGROUNDRuss 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.
PMID: 35503318BACKGROUNDSanders 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.
PMID: 28817114BACKGROUNDSamane 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.
PMID: 34991513BACKGROUNDPineda 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.
PMID: 29059481BACKGROUNDThoyre 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.
PMID: 15960007BACKGROUNDLubbe 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.
PMID: 28251754BACKGROUNDCrapnell 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.
PMID: 23952198BACKGROUNDAdams-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.
PMID: 23582139BACKGROUNDGoday 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.
PMID: 30358739BACKGROUNDAlshaikh 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.
PMID: 35301017BACKGROUNDMacias 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.
PMID: 37862366BACKGROUNDHannan 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.
PMID: 32253024BACKGROUNDEdwards 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.
PMID: 31296918BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ravi Mishra, MBBS, MD
Advocate Illinois Masonic Medical Center
- PRINCIPAL INVESTIGATOR
Elizabeth Jensen, MPH, PhD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Joseph Chase, MPH
Advocate Aurora Research Institute
- PRINCIPAL INVESTIGATOR
Anne Albi, BS, MS
Advocate Illinois Masonic Medical Center
- PRINCIPAL INVESTIGATOR
Cynthia Lira-Crame, BSN, MSN
Advocate Illinois Masonic Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2025
First Posted
August 22, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share