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NCT07136610NARecruiting

Standardized Application of Feeding Evaluations Using SMART Tool

Wake Forest University Health Sciences

Start Date

8/1/2025

Completion Date

7/1/2027

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.

Detailed 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).

Eligibility Criteria

Age Range: No minimum to 1 years

Inclusion Criteria: * Infants born between August 1, 2025, and July 31, 2026, AND admitted to NICU Exclusion Criteria: * No oral feeding started by July 15, 2026

Interventions

BEHAVIORAL

SMART Tool

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Conditions

Infant and Young Child Feeding

Locations

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