Standardized Application of Feeding Evaluations Using SMART Tool

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Length of hospital stay [Срок оценки: Month 6]
• Number of days to full oral feeds [Срок оценки: Month 6]
• Percent of Nasogastric tube days [Срок оценки: Month 6]

Вторичные конечные точки (1)

• Home Tube Feeding [Срок оценки: Month 6]

Критерии участия

Критерии включения

• Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU

Критерии исключения

• No oral feeding started by July 15, 2026

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 14 центров

• Advocate Good Shepherd Hospital — Barrington
• Advocate Trinity Hospital — Chicago
• Advocate Sherman Hospital — Elgin
• Advocate Condell Medical Center — Libertyville
• Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn) — Oak Lawn
• Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge) — Park Ridge
• Aurora Medical Center Grafton — Grafton
• Aurora BayCare Medical Center — Green Bay
• … и ещё 6 центров

Публикации

• 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. PMID 16829207
• 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. PMID 37203433
• 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. PMID 39568619
• 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. PMID 32859958
• 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. PMID 35503318
• 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. PMID 28817114
• 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. PMID 34991513
• 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. PMID 29059481

Идентификаторы

NCT: NCT07136610 · IRB00132685

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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