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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART Tool | Experimental | Feeding skill assessment, the SMART Tool to monitor infant feeding skill development in the neonatal intensive care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART Tool | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Home Tube Feeding | Proportion of infants discharged home with nasogastric tube or gastrosotomy tubes | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ravi Mishra, MBBS,MD,FAAP | Contact | 804.464.7472 | ravi.mishra@aah.org | |
| Cynthia Liracrame, RN | Contact | 773.296.7977 | cynthia.liracrame@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Ravi Mishra, MBBS, MD | Advocate Illinois Masonic Medical Center | Study Chair |
| Elizabeth Jensen, MPH, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Good Shepherd Hospital | Recruiting | Barrington | Illinois | 60010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16829207 | Background | 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. | |
| 37203433 | Background | 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. |
| Label | URL |
|---|---|
| Psychometric Properties of the SMART Feeding Tool | View source |
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|
|
| 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 | Principal Investigator |
| Advocate Trinity Hospital | Recruiting | Chicago | Illinois | 60617 | United States |
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| Advocate Sherman Hospital | Recruiting | Elgin | Illinois | 60123 | United States |
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| Advocate Condell Medical Center | Recruiting | Libertyville | Illinois | 60048 | United States |
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| Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn) | Recruiting | Oak Lawn | Illinois | 60453 | United States |
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| Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge) | Recruiting | Park Ridge | Illinois | 60068 | United States |
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| Aurora Medical Center Grafton | Recruiting | Grafton | Wisconsin | 53024 | United States |
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| Aurora BayCare Medical Center | Recruiting | Green Bay | Wisconsin | 54311 | United States |
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| Aurora Medical Center Kenosha | Recruiting | Kenosha | Wisconsin | 53142 | United States |
|
| Aurora Sinai Medical Center | Recruiting | Milwaukee | Wisconsin | 53233 | United States |
|
| Aurora Medical Center Oshkosh | Recruiting | Oshkosh | Wisconsin | 54904 | United States |
|
| Aurora Medical Center - Sheboygan County | Recruiting | Sheboygan | Wisconsin | 53081 | United States |
|
| Aurora Medical Center - Summit | Recruiting | Summit | Wisconsin | 53066 | United States |
|
| Aurora West Allis Medical Center | Recruiting | West Allis | Wisconsin | 53227 | United States |
|
| 39568619 | Background | 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. |
| 32859958 | Background | 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. |
| 35503318 | Background | 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. |
| 28817114 | Background | 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. |
| 34991513 | Background | 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. |
| 29059481 | Background | 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. |
| 15960007 | Background | 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. |
| 28251754 | Background | 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. |
| 23952198 | Background | 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. |
| 23582139 | Background | 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. |
| 30358739 | Background | 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. |
| 35301017 | Background | 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. |
| 37862366 | Background | 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. |
| 32253024 | Background | 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. |
| 31296918 | Background | 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. |
| Psychometric Properties of SMART Feeding Tool - AHMW SHARE | View source |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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