Standardized Application of Feeding Evaluations Using SMART Tool

Last updated: August 27, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Feeding

Treatment

SMART Tool

Clinical Study ID

NCT07136610
IRB00132685
  • Ages < 1
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • No oral feeding started by July 15, 2026

Study Design

Total Participants: 3500
Treatment Group(s): 1
Primary Treatment: SMART Tool
Phase:
Study Start date:
August 01, 2025
Estimated Completion Date:
July 31, 2026

Study Description

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).

Connect with a study center

  • Advocate Good Shepherd Hospital

    Barrington, Illinois 60010
    United States

    Site Not Available

  • Advocate Trinity Hospital

    Chicago, Illinois 60617
    United States

    Site Not Available

  • Advocate Sherman Hospital

    Elgin, Illinois 60123
    United States

    Site Not Available

  • Advocate Condell Medical Center

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Advocate Good Shepherd Hospital

    Barrington 4884116, Illinois 4896861 60010
    United States

    Active - Recruiting

  • Advocate Trinity Hospital

    Chicago 4887398, Illinois 4896861 60617
    United States

    Active - Recruiting

  • Advocate Sherman Hospital

    Elgin 4890864, Illinois 4896861 60123
    United States

    Active - Recruiting

  • Advocate Condell Medical Center

    Libertyville 4899739, Illinois 4896861 60048
    United States

    Active - Recruiting

  • Advocate Christ Medical Center (Advocate Children's Hospital - Oak Lawn)

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Active - Recruiting

  • Advocate Lutheran General Hospital (Advocate Children's Hospital - Park Ridge)

    Park Ridge 4905367, Illinois 4896861 60068
    United States

    Active - Recruiting

  • Aurora Medical Center Grafton

    Grafton, Wisconsin 53024
    United States

    Site Not Available

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin 54311
    United States

    Site Not Available

  • Aurora Medical Center Kenosha

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin 53233
    United States

    Site Not Available

  • Aurora Medical Center Oshkosh

    Oshkosh, Wisconsin 54904
    United States

    Site Not Available

  • Aurora Medical Center - Sheboygan County

    Sheboygan, Wisconsin 53081
    United States

    Site Not Available

  • Aurora West Allis Medical Center

    West Allis, Wisconsin 53227
    United States

    Site Not Available

  • Aurora Medical Center Grafton

    Grafton 5254739, Wisconsin 5279468 53024
    United States

    Active - Recruiting

  • Aurora BayCare Medical Center

    Green Bay 5254962, Wisconsin 5279468 54311
    United States

    Active - Recruiting

  • Aurora Medical Center Kenosha

    Kenosha 5258393, Wisconsin 5279468 53142
    United States

    Active - Recruiting

  • Aurora Sinai Medical Center

    Milwaukee 5263045, Wisconsin 5279468 53233
    United States

    Active - Recruiting

  • Aurora Medical Center Oshkosh

    Oshkosh 5265838, Wisconsin 5279468 54904
    United States

    Active - Recruiting

  • Aurora Medical Center - Sheboygan County

    Sheboygan 5272893, Wisconsin 5279468 53081
    United States

    Active - Recruiting

  • Aurora Medical Center - Summit

    Summit, Wisconsin 5279468 53066
    United States

    Active - Recruiting

  • Aurora West Allis Medical Center

    West Allis 5278420, Wisconsin 5279468 53227
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.